The Pharma Legal Handbook: Malaysia

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The Pharma Legal Handbook: Malaysia answers essential questions about the legal and regulatory environment for pharmaceuticals in Malaysia. It is a must-have for any company operating in the country or looking to enter the market.

Prepared in association with Skrine, a leading Malaysian law firm, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents, medical cannabis, cannabinoid medicines and opioids.

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October 2019

1. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Malaysia

Cannabinoid drugs, medicinal cannabis and opioid drugs in Malaysia – a comprehensive legal overview. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.

CANNABINOID DRUGS

1. Are Cannabinoid Drugs authorized in your country?

The Malaysian regulatory authority does not authorise the use or sale of any specific drug per se, i.e. cannabinoid drugs, rather it regulates the registration of products which may include cannabinoid drugs as an active ingredient of such products. Products are registered on a case by case basis.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The primary authority with jurisdiction over Cannabinoid Drugs is the National Pharmaceutical Regulatory Agency (NPRA) established under the Ministry of Health (MOH) of Malaysia.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

We are not aware of any such regulatory framework in Malaysia. The only relevant regulatory framework lies in the registration of a product which may include Cannabinoid Drugs as an ingredient, and this would be carried out in accordance with the general authorisation, pricing and reimbursement scheme for registration of any product, medicine or device.

4. Which are the cannabinoid drugs that have received market approval to date?

Please see our comments in Question 1 above – there is therefore no Cannabinoid Drugs per se that has been approved to date.

5. Who can prescribe Cannabinoid Drugs?

We are not aware of anyone who can prescribed Cannabinoid Drugs. Upon registration of a product containing Cannabinoid Drugs however, any registered medical practitioner, registered dentist and registered veterinarian may prescribe the said product.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

We are not aware of any list of doctors who are authorised to prescribe Cannabinoid Drugs. As long as a product containing Cannabinoid Drugs is registered, any doctor registered with the relevant council may prescribe the use of the said product.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

We are not aware of any approval or notification required to prescribed Cannabinoid Drugs. The only approval we are aware of is from the NPRA for the registration of products containing Cannabinoids.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

We are not aware of any organisations authorised to sell/distribute Cannabinoid Drugs. Upon registration of a product it may be prescribed by a registered medical practitioner, registered dentist or registered veterinaries who would be authorised to sell/distribute the product containing the Cannabinoid Drug or by a licenced pharmacist.

9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?

We are not aware of any list of retailers/distributors authorised to sell Cannabinoid Drugs in Malaysia.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

We are not aware of any current proposal or reforms to the regulation of Cannabinoid Drugs. But we are made to understand that there are proposal and reforms to the status, legality and authorisation of Cannabis which may affect the status of Cannabinoid Drugs in the future. This is elaborated in Question 13 below.

11. When are they likely to come into force?

Not applicable.

MEDICINAL CANNABIS

12. Is Medicinal Cannabis authorized in the country?

The Malaysian regulatory authority does not authorise the use or sale of Cannabis in Malaysia. It recognises the strains of active ingredients in Cannabis which is used in products that are registered with the relevant authority. Such products are registered on a case by case basis. In addition, Cannabis is a drug controlled under the Dangerous Drug Act 1952 (“DDA 1952”) and in accordance with the provisions of that Act, the Minister charged with the responsibility for medical and health services (“the Health Minister”) may authorise the cultivation of Cannabis for medicinal purposes, however to date, no such authorisation has been granted.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

The primary authority with jurisdiction over Cannabis is the NPRA as is with all substance deemed to be a Dangerous Drug.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Whilst there are statutory provisions which empowers the Health Minister to regulate the authorisation of Cannabis for medicinal purposes, there is to date no such regulatory framework in place. The only relevant regulatory framework lies in the registration of a product which may include Cannabis as an ingredient, and this would be carried out in accordance with the standard authorisation, pricing and reimbursement scheme for registration of any product, medicine or device.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

The production (manufacturing) and importation of medicinal cannabis is regulated by the NPRA. No cannabis, even for medicinal purposes, may be imported or produced without authorisation from the Health Minister. The NPRA does not authorise or regulate the production or importation of Cannabis, even for medicinal purpose but rather it regulates the production and import of products, which may contain Cannabis as an ingredient. In any event, all such products must be registered with NPRA.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

The production and/or cultivation of Cannabis for medical purposes can only be authorised by the Health Minister and we are not aware of any such authorisation that has been issued to any person(s). Where any person(s) intend to import a dangerous drug, such as Cannabis, into Malaysia, an import authorisation in the prescribed form (Form C of the DDA 1952) must be approved by the Health Minister who will then issue an import certificate according to the prescribed Form A set out in the Second Schedule of the DDA 1952 which must be forwarded by the intending importer to the person from whom the drug is to be obtained. If the importer to whom the import authorisation is issued intends to import the drug in more than one consignment, a separate approval of import certificate must be obtained for each consignment.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Cannabis cannot be marketed and distributed in Malaysia, even for medical purposes.

18. How can patients obtain Medicinal Cannabis?

Patients cannot obtain Medicinal Cannabis per se, only the products which may contain Cannabis as an ingredient. In the event that Health Minster approves of the importation of Cannabis in accordance with the procedure stated in Question 16 above, it can only be prescribed by licenced bodies or registered medical practitioners, registered dentists and registered veterinarians authorised by the Health Minister to make such prescriptions.

19. Who can prescribe Medicinal Cannabis?

We are not aware of anyone who can prescribe Medicinal Cannabis.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

We are not aware of any list of doctors authorised to prescribe Medicinal Cannabis.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

We are not aware of any approval or notification required to prescribe Medicinal Cannabis as this is not permitted in Malaysia. The only approval required, is from the NPRA for the registration of products which may contain Cannabis as an ingredient for medicinal purposes.

22. Where is Medicinal Cannabis available?

We are not aware of anywhere in Malaysia which Medicinal Cannabis is made available.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

We are not aware of any list of reatilers who are autorished to sell Medicinal Cannabis.

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

We are made to understand that the Malaysia Psychiatric Association has called on the government to set up a review committee, consisting of medical and legal professionals, academicians and researchers, and other stakeholders in the community to review the status of medical cannabis before deciding on the legalisation of Cannabis in Malaysia as a whole.¹ However, as of June 2021, there is no indication that medical cannabis is set to be legalised in Malaysia.

OPIOID DRUGS

25. Are Opioid Drugs authorized in your country?

Yes, opioids are controlled drugs under the Dangerous Drugs Act 1952 and are commonly used in Malaysia. The types of opioids used in particular are weak opioids i.e. dihydrocodeine, tramadol and tramadol combinations rather than strong opioids i.e. morphine, oxycodone, pethidine and fentanyl.²

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The primary regulating authority on the possession, importation and exportation of raw opium is the NPRA under the MOH. In addition, the Poisons Board is an advisory board which reviews the list of poisons including opioid and is called upon to advise the Minister of Health on matters relating to poisons. The NPRA has jurisdiction over the registration of any drug-related product including those with opioid constituents.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

We are not aware of any regulatory framework for the authorisation of Opioid Drugs per se, rather all products constituting any traces of various types of Opioids as an active ingredient must go through the necessary registration with NPRA, without which it cannot be sold or used in Malaysia. We are also not aware of any regulatory framework for the pricing and reimbursement of Opioid Drugs.

28. Which are the Opioid drugs that have received market approval to date?

We are not aware of any Opioid drugs that have received market approval to date. However, there have been products registered in Malaysia which include Opioid Drugs as an active ingredient such as tramadol, codeine, dihydrocodeine morphine, oxycodone, pethidine, fentanyl and methadone.

29. Who can prescribe Opioid Drugs?

Opioid drugs are considered psychotropic substances and are thus regulated by the Poisons (Psychotropic Substances) Regulation 1989. Under the said regulation only a specific class of persons is permitted to possess psychotropic substances, and only a registered medical practitioner, registered dentist Division I, a veterinary surgeon or a person acting in accordance with the direction of a registered medical practitioner, registered dentist Division I or a veterinary surgeon is permitted to prescribe these psychotropic substances, like products containing Opioid Drugs.³

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

We are not aware of any list of doctors authorised to prescribe Opioid Drugs.

31. What approvals or notifications are required to prescribe Opioid Drugs?

The main requirement for the prescription of psychotropic substances including Opioid Drugs as an active ingredient, is that the prescriber must be registered with the appropriate authorities, for medical practitioner with the Malaysian Medical Council, for dentists with the Malaysian Dental Council and for veterinarians with the Malaysian Veterinary Council.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

The only person(s) permitted to dispense any psychotropic substance whether or not for medical, dental or animal treatment is a licensed pharmacist or a pharmacist in the public service.

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

We are not aware of any list of retailers/distributors authorised to sell Opioid Drugs in Malaysia.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

We are not aware of any proposals for reform or significant change to the regulation of Opioid Drugs given that these drugs are not being regulated in their raw form. We are not aware of any plans to reform the registration of products containing Opioid Drugs as active ingredients.

35. When are they likely to come into force?

Not applicable.

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Set up medical marijuana review committee, says psychiatric association, The Star Online, 2018 at: https://www.thestar.com.my/news/nation/2018/10/09/set-up-medical-marijuana-review-committee/
Trends and patterns of analgesic prescribing in Malaysian public hospitals from 2010 to 2016: tramadol predominantly used, US National Library of Medicine National Institutes of Health, Journal of Pain Research., Dovepress. 2018 at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6160284/
Regulation 3 and regulation 16 of the Poisons (Psychotropic Substances) Regulations 1989.

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2. Regulatory Reforms: Malaysia

An insight into regulatory reforms in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.

1. Are there proposals for reform or significant change to the healthcare system?

The followings are some of the regulatory proposals and reforms in the pharmaceutical industry in Malaysia:

i) online registration system. In 2017, the NPRA, MOH officially launched the upgraded online registration system, QUEST3+ including a membership registration module, a helpdesk module, admin module and cosmetic notification module and offer online payment services;

ii) online ADR reporting system. In 2017, the NPRA also launched an online ADR reporting system known as ConSERF Online;

iii) development of the Malaysian herbal monograph. This monograph was established under the National Key Economic Areas and the project has developed 10 herbal monographs which aids in ensuring that the production of local traditional products are safe, of high quality, competitive and comply with international standards;

iv) In 2006, the Malaysian National Medicines Policy (MNMP) was established to meet the Malaysian healthcare needs. Under this policy the Pharmacy Research Priorities was issued in order to further support the 11th Malaysia Plan, Ministry of Health Strategic Plan 2016-2020 and the Pharmacy Programme Strategic Plan 2017-2010. The report suggested that the areas which are given priority for research are as follows:

1. access to medicines
2. monitoring and evaluation of outcomes
3. quality and safe use of medicine and sustainability
4. optimization of therapy and pharmacy services delivery
5. national databases/big data analytics, the aim of this Pharmacy Research Priorities gives an indication of the areas that will be focused on by individuals and healthcare organisations who conduct pharmacy researches in Malaysia;

v) price controls on pharmaceuticals and professional fees to reduce the costs incurred by the population. The Malaysian government published guidelines on professional fees under the Private Health Care Facilities and Services Act 1998 and 2006 Regulations. The Malaysian Medical Association also issued a recommended fee schedule that is now in place as a benchmark for professionals;

vi) advertisement of medical devices. The MDA has prepared a draft Code of Advertising for Medical Devices with the aim to help the industry and healthcare professional in complying with the Medical Device Act 2012 and MDA’s regulations.

The following are the 2021 budget updates with regard to the healthcare industry and the Covid-19 pandemic:

While the 2021 budgets shows massive cuts across all healthcare specialties, massive changes were also announced during budget 2021 as a means of combating the Covid-19 Pandemic. These include inter alia: (i) The National Development Scheme, with a budget of RM1.4 billion. This programme helps to strengthen the domestic supply chain and boosts the manufacturing of medical devices made locally. (ii) There are also RM1.4 billion in concessions for the privatisation of medical laboratories and stores. (iii) The Peka B40 project, which has a budget of RM80 million, aims to meet the non-communicable disease (NCD) healthcare needs of the bottom 40% of the population (B40). (iv) specific programme allocation of RM2.89 billion for health facilities and medical supplies is also included in the budget. (v) The Malaysian government is allocating RM35 million (US$8 million) to the Malaysia Healthcare Travel Council in order to boost the local health tourism industry’s competitiveness. Malaysian income tax exemptions for the export of private healthcare services will be extended through the 2022 assessment year.

2. When are they likely to come into force?

Many of the proposals and recommendations for the healthcare industry are still in the research and/or discussion stages and we therefore cannot confirm any fixed date for the implementation of any of the proposed reforms.

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3. Patents and Trademarks: Malaysia

The key facts about patents and trademarks in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.

1. What are the basic requirements to obtain patent and trademark protection?

Patent and trademark laws in Malaysia are mainly codified in statutes, but its jurisprudence is derived from the United Kingdom’s common law. Thus, there are similarities between the two jurisprudences, including the recognition of the tort of passing off as a cause of action.
The Patents Act 1983 (“PA 1983”) provides for the protection of patentable inventions and utility innovations. An invention may be or may relate to a product or a process.¹ A patentable invention must² (i) be novel, (ii) involve an inventive step, and (iii) be industrially applicable. An innovation includes a new product or process, or any new improvements to a known product or process, including an invention³ To obtain utility innovation protection, the innovation must⁴ be (i) new, and (ii) industrially applicable.
Trademark protection is now governed by the Trademarks Act 2019 (“TMA 2019”) which repealed Trade Marks Act 1976. The TMA 2019 explicitly affords protection to non-traditional signs such as shape of goods or their packaging, colour, sound, scent, hologram, positioning, and sequence of motion, so long as⁵ the sign is (i) capable of being represented graphically, and (ii) capable of distinguishing goods or services of one undertaking from another. Prior use is not necessary to apply for the registration of a trademark; a bona fide proprietor may apply if the proprietor is using or intends to use the trademark in the course of trade.⁶

2. What agencies or bodies regulate patents and trademarks?

The Intellectual Property Corporation of Malaysia (“MyIPO”), which houses the Registrar of Patents and the Registrar of Trademarks, is the agency responsible for regulating the registration or recordal of intellectual property rights in Malaysia.
While the Registrar of Trademarks may hear applications to revoke a registered trademark and preside over opposition proceedings under certain provisions of the TMA 2019, the Registrar of Patents does not have similar powers for patents under the PA 1983. There are no opposition proceedings under the PA 1983 and invalidation actions are heard by the High Court at first instance.

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

1. The PA 1983 proscribes the following as non-patentable inventions⁷ (and innovations)⁸:

discoveries, scientific theories, and mathematical methods;
plant or animal varieties or essentially biological processes for the production of plants or animals, other than man-made living micro-organisms, micro-biological processes, and the products of such micro-organism processes;
schemes, rules, or methods for doing business,
performing purely mental acts or playing games;
methods for the treatment of human or animal body by surgery or therapy, and diagnostic methods practiced on the human or animal body (except for products used in any such methods);

2. The Registrar of Patents will also refuse to grant patent protection⁹ (or utility innovation protection)¹⁰:

where the performance of any act in respect of the claimed invention is contrary to public order or morality;
where it appears that the grant of patent protection would be prejudicial to the interest or security of the nation.

3. The application for the registration of a trademark may be refused for various reasons including the following non-exhaustive list¹¹:

if the use of the trademark is likely to deceive or cause confusion to the public or contrary to any written law;
if it is of such a nature as to deceive or mislead the public as to the nature, quality or geographical origin of the goods or services;
the trademarks are contrary to public interest or to morality;
the trademarks contain or consist of any scandalous or offensive matter or would otherwise not be entitled to protection by any court of law;
the trademarks contain a matter which is in the opinion of the Registrar is or might be prejudicial to the interest or security of the country;
the trademarks contain or consist of the name or representation of another person whether living or dead unless the applicant furnishes the Registrar with the consent of that person, if living, or of the representative of that person if deceased;
the trademarks contain or consist of a flag of a country, national emblem, emblem, insignia or royal arms unless the applicant furnishes the Registrar with the authorisation of the competent authorities or international intergovernmental organisation;
the trademarks contain or consist of a word which is commonly used as or is the accepted name of any single chemical element or single chemical compound, as distinguished from a mixture, or which is declared by the World Health Organization as an international non-proprietary name or which is deceptively similar to such name (there are exceptions to this);
the trademarks contain or consists of “Patent”, “Patented”, “By Royal Letters Patent”, “Registered”, “Registered Design”, and “Copyright” or words to the like effect in any language whatsoever, or a sign similar to any of those signs as is likely to be taken for that sign; or
if the trademark is identical or there is a likelihood of confusion with an earlier trademark and the goods or services for which the trademark is applied for are identical with the goods or services of the earlier trademark.

4. How can patents and trademarks be revoked?

1. Patent and utility innovation invalidation actions must be filed in the High Court, not at the Registry of Patents. Grounds for invalidation include¹²:

the invention or innovation does not fulfil the requirements set out in the PA 1983;
the invention or innovation is excluded from protection under the PA 1983;
the description or claim does not comply with the requirements of the PA 1983 and the Patent Regulations 1986 (“PR 1986”);
the necessary drawings have not been furnished to the Registry;
the right to the patent or utility innovation does not belong to the person to whom the patent was granted;
incomplete or incorrect information has been deliberately provided or caused to be provided to the Registrar of Patents.

2. Under the TMA 2019, the Registrar of Trademarks has the power to revoke the registration of a trademark where:

the Registrar failed to take into account (i) a validly filed notice of opposition or (ii) a validly filed application for extension of time to oppose the registration, when it decided to register the trademark¹³, or
if the Registrar is satisfied that the registration should be revoked considering Malaysia’s obligations under an international agreement or convention or any special circumstances.

3. An aggrieved person may apply to the High Court for the revocation of a trademark registration on, among others, the following grounds¹⁴:

if there is no good faith use of the trademark for a continuous period of three years and there are no proper reasons for the non-use;
in the instance of genericide as a result of any action or omission on the part of the registered proprietor;
if the use of the trademark is liable to mislead the public;
if the application for registration should have been refused by the Registrar of Trademarks based on the absolute grounds for refusal of registration such as if the trademark is not capable of distinguishing the registered proprietor’s goods or services or is devoid of distinctive character, or if the trademark consists exclusively of signs or indications which may serve, in trade, to designate the characteristics of the goods or services, or if the trademark consists exclusively of signs or indications which have become customary in the local language or established practices of the trade;
if there is an earlier trademark right;
if the registration was obtained by fraud or misrepresentation.

5. Are foreign patents and trademarks recognized and, if so, under what circumstances?

Patent applications may claim priority of one or more earlier national, regional, or international applications filed pursuant to the Paris Convention for the Protection of Industrial Property or the Patent Cooperation Treaty.¹⁵ The Malaysian application must be made within 12 months of the earlier application.¹⁶
The PR 1986 allows requests for modified substantive examination (a simplified examination process) of international applications to be made if a corresponding Australian, Japanese, South Korean, UK, US, or European patent has been granted for the same invention.¹⁷
Malaysia has acceded to the Madrid Protocol and under the TMA 2019, brand owners may designate Malaysia in the international applications for registration of trademarks.
Separately, trademark applications may claim priority from applications filed in a member state of the Paris Convention¹⁸ or any country declared to have arrangements with Malaysia for the reciprocal protection of trademarks.¹⁹ The Malaysian application must be made within 6 months of the earlier application.²⁰
An applicant for registration of a trademark may apply for temporary protection of a trademark which is the subject matter of an exhibition at an official or officially recognised international exhibition held in Malaysia or in any member state of the Paris Convention or declared foreign country.²¹
A well-known trademark is entitled to protection regardless if the trademark has been registered in Malaysia or if the proprietor does not carry on business or has any goodwill in Malaysia.²²

6. Are there any non-patent/ trademark barriers to competition to protect medicines or devices?

All medicines must obtain prior marketing authorisation from the National Pharmaceutical Regulatory Agency. The marketing authorisation holder may also apply for data exclusivity.
All medical devices must register with the Medical Device Authority prior to being imported, exported, or placed in the market. Any establishment intending to import, export, or place in the market any registered medical device must first obtain an establishment license from the Medical Device Authority.

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

There are no specific restrictions on the types of medicines or devices that can be granted patent or trademark protection save for the general restrictions as described above.

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

The PA 1983 is equivocal as to whether a patent licence agreement must be entered into the Register of Patents; it provides that “where a licence contract is concluded between the parties, the contracting parties shall inform the Registrar accordingly”²³. It is unclear as to whether this provision applies to all licence agreements or only licence agreements which have been initiated or negotiated by way of the mechanism set out in the preceding sub-sections 42(1) and 42(2). This issue has yet to be determined by the Malaysian courts but there may be risks associated with not recording such licences if the Malaysian courts ultimately determine that section 42(3) renders such recordals mandatory, including potential quasi-criminal liabilities for causing false entries in the Register.²⁴ it is advisable that out of abundance of caution, all licence agreements are to be entered into the Register.
The TMA 2019 suggests²⁵ that a licence agreement should be approved by the Registrar of Trademarks, but the consequences for failure to apply for approval do not appear to apply to licence agreements.²⁶ The TMA 2019 deems²⁷ notice of a licence if the particulars of the licence have been entered in the Register, but the provision does not mandate a requirement to apply for approval of the licence agreement. Unlike the position under the Trade Marks Act 1976, the TMA 2019 allows²⁸ for licensees to take action against infringers in certain circumstances and in relation to revocation actions for non-use, the TMA 2019 will consider use with the registered proprietor’s consent²⁹ to be use of the trademark without having to register the licence agreement. However, there may still be some risks associated with the non-registration of licence agreements: paragraph 12(1) of the Guidelines of Trademarks 2019 issued by the MyIPO suggests that the MyIPO requires the particulars of licensing agreements to be registered and the TMA 2019 requires compliance³⁰ with guidelines issued by the Registrar of Trademarks. Failure to comply may render an application as withdrawn, lapsed, refused, revoked, or as determined by the Registrar or may be an offence and shall, on conviction, be liable to a fine not exceeding MYR10,000.00.³¹

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PA 1983, section 12
PA 1983, section 11
PA 1983, section 17
PA 1983, section 17
TMA 2019, section 3(1)
TMA 2019, section 17(1)(a)
PA 1983, section 13(1)
PA 1983, section 17A(1)
PA 1983, sections 31 and 85
PA 1983, section 17A
TMA 2019, sections 23(1), 23(5) and 24
PA 1983, sections 17A and 56
TMA 2019, section 4591)
TMA 2019, sections 46 and 47
PA 1983, section 27(1)
PA 1983, section 27(1A)
PR 1986, regulation 27A
TMA 2019, section 26(1)
TMA 2019, section 27
TMA 2019, section 26(1)
TMA 2019, section 28
TMA 2019, section 76
PA 1983, section 42(3)
PA 1983, section 63
TMA 2019, section 65(1)
TMA 2019, section 65(4)
TMA 2019, section 69(5)
TMA 2019, section 70(3)
TMA 2019, section 46(1)(a)
TMA 2019, section 160(3)
TMA 2019, section 160(6)

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4. Product Liability: Malaysia

All legal aspects surrounding product liability in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.

1. What types of liability are recognized in your jurisdiction?

Product liability for medicines can arise through several grounds of action. These include liability arising from the tort of negligence or strict liability or from breach of contract. Since 1999, the Consumer Protection Act was enacted to protect consumers from defective or dangerous products (purchased for private or non-commercial purposes) that cause serious health risks or death. In addition, criminal liability may also arise under the Poisons Act 1952, the Sale of Drugs Act 1952, Dangerous Drugs Act 1952 and under the Penal Code.

Violation of laws and regulations may result in civil liabilities, administrative penalties and criminal liabilities such as:

Civil Liability

discontinuance of infringements;
restitution (restoration of original condition);
specific performance;
compensation for loss;
payment for breach of contract damages; and
compensation for the defective product.

Administrative Liability

warning;
fine;
forfeiture of illegal earnings, forfeiture of illegal property;
search and seizure warrant;
power to enter premises and take samples;
order to stop production and business;
closure orders (order to close premises, building or facility);
impose conditions on permits and licences;
suspension or withdrawal of permits, suspension or withdrawal of licences; and
other administrative punishments as stipulated by law or administrative regulations.

Criminal Liability

fines;
confiscation of property;
criminal detention;
fixed-term imprisonment;
life imprisonment; and
death penalty.

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Under s.68 of the Consumer Protection Act 1999, where any damage is caused wholly or partly by a defect in a product, the following persons shall be liable for the damage:

the producer (i.e., manufacturer) of the product;
the person who, by putting his name on the product or using a trademark in relation to the product, has held himself out to be the producer of the product; and;
the person who has, in the course of his business, imported the product into Malaysia in order to supply it to another person.

An action for breach of contract may be brought for a violation of express or implied contractual terms. For example, under the Sale of Goods Act 1957, where there is a breach of an implied agreement that goods (medicines or devices) supplied should be of satisfactory quality.

The authorized officer under the TCMA 2016 may enforce his powers of investigation and impose a stop order requiring a practitioner to stop and cease practicing in a practice area or a closure order for any premises, building or facility. The authorised officer also possesses other administrative powers such as applying for a search and seizure warrant, power to enter premises and taking of samples.

Nevertheless, the primary penalty stated in the various Malaysian legislations for any defects in medical products and devices lie in criminal liability with the imposition of fines or fixed-term imprisonment. There are no provisions for a compensatory regime following any civil liabilities.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

These liabilities extend to corporate executives, employees and representatives of a company. For example, a director or legal representative in breach of his fiduciary duty or breach of trust or duty may face civil, administrative and/or criminal liabilities.

4. How can a liability claim be brought?

Civil Claims

Civil liability claims can be brought up by the aggrieved party as plaintiff in a civil court, or through arbitration if there is an arbitration clause in the underlying transaction document. The Tribunal for Consumer Claims (established under section 85, Part XII of The Consumer Protection Act 1999) was formed to provide an aggrieved party with an alternative to the civil courts for seeking redress for purchases of products or services made from traders or service providers.

Administrative Claims

These actions are usually brought by the relevant regulators (i.e. NPRA, MDA, TCM Council, etc.) against the party in breach of their statutory duties or licensing obligations. Additional penalties may be imposed such as fines and/or revocation of licence.

Criminal Claims

Following a complaint brought by a consumer or the relevant regulator, if it is discovered that a director or employees or representatives of a company has committed a criminal offence, the public prosecutor will then follow up on the investigation and potentially institute prosecution proceedings against the Defendant in the criminal court.

5. What defences are available?

The defences available for any person in respect of a defect in a product are as such: –

that the defect is attributable to compliance with any requirement imposed under any written law;
that he did not at any time supply the defective product to another person;
that the defect did not exist in the product at the relevant time;
that the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description as the product in question may reasonably be expected to discover the defect if it had existed in his product while it was under his control; or
that the defect is in a subsequent product to which the defective product was added to and that the defect is wholly attributable to the design of that subsequent product or compliance by the producer of the product in question with instructions given by the producer of the subsequent product.
Defences to an action in tort includes voluntary assumption of risks, contributory negligence, unforeseeability or remoteness of harm, and absence of breach of the standard of care.
Defences to a claim for breach of contract include waiver, laches, and estoppel.
Defences to statutory liability vary and are set out in the relevant legislations.

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5. Traditional Medicines and OTC Products: Malaysia

A brief overview of the situation regarding traditional medicines and OTC products in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Alternative medicine is regulated by the Traditional and Complementary Medicine Council (“TCM Council”) established under the Traditional and Complementary Medicine Act 2016 (“TCMA 2016”). Traditional and complementary medicine can only be practised in recognised practice areas decided by the Minister of Health. Regulation of traditional medicines follow pharmaceutical products in that they must be registered with the DCA and be given a registration number. All traditional medicine is prohibited from containing any caffeine, nicotinamide, paracetamol and poison within the meaning of the Poisons Act 1952 [Act 366].

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Yes, only products registered with the DCA may be advertised and this includes any traditional, herbal, complementary, or alternative products.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Items that must be included on the natural products (including traditional, herbal, complementary and alternative product) are as follows: –

product name;
dosage form;
name of active ingredient, including part of plant used;
strength of active ingredient in weight;
indication;
batch number;
manufacturing date;
expiry date;
dosage/use instruction;
storage condition(s);
registration number (MAL);
name and address of product registration holder;
name and address of manufacturer;
warning label;
pack size;
name and strength of preservative;
name and content of alcohol (where present);
declaration on the source of ingredients derived from animal origin;
additional statement;
contraindication/precaution;
security label;
product description; and
date of revision.
To declare the source of capsule shell (if applicable)
Recommended daily allowance (RDA) for vitamins/ multivitamins/Mineral preparations used as xxvi) dietary supplements (optional)
The words “Keep medicine out of reach of children” or words bearing similar meaning in both Bahasa Malaysia & English
other country specific labelling requirements (if applicable)¹

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

In Malaysia, pharmaceutical products are defined as either scheduled poisons, non-scheduled poisons or natural products under the Poisons Act 1952 (“1952 Act”). Scheduled poisons (also referred to as controlled medicine) are listed in the First Schedule of the 1952 Act. Non-scheduled poisons are products that do not contain scheduled poisons and are also known as over-the-counter (“OTC”) products.² All products, including OTCs in Malaysia must be registered. Before registration, each product must undergo either a full or abridged evaluation. Those not listed in the Drug Registration Guidance Document (“DRGD”) for abridged evaluation will receive full evaluation.³

5. Are there any limitations on locations or channels through which OTC products may be sold?

All products including OTCs in Malaysia can only be sold by a person or business which holds the appropriate licence issued under the CDCR 1984.

6. What health, advertising, and marketing claims may be made for OTC products?

Advertising of OTC products must be factually true and cannot mislead the public, excluding any direct or implied exaggerated claim and superlatives. The word “safe” must not be used without qualification and claims must not state categorically that a product has no side effects, toxic hazards or risk of addiction.⁴ Reference to speed of absorption, dissolution, distribution and other preliminary activity are acceptable when supported by appropriate evidence.⁵ Comparisons may be made so long as they do not mislead consumers.⁶

7. Can OTC products be marketed or advertised directly to the public?

Yes, all marketing activities for OTC products are regulated by the Code of Conduct for Non-Prescription (OTC) Products issued by the Pharmaceutical Association of Malaysia and must conform to all existing governmental legislation governing the practice of pharmaceutical industry in Malaysia.

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

Given that all drugs are classified under the Poisons Act 1952 and prescription-only products should be scheduled poisons, they cannot strictly be converted in or out of the scheduled poisons list. The matter must be brought before the Poisons Board who will then hold a meeting to decide whether to table a specific drug as a scheduled poison or an OTC and this will then be brought before the Health Minister for consideration and to make the necessary regulation on such product(s).

9. What are the requirements for the importation of either traditional medicines or OTC products?

Traditional medicines and OTC products may be imported into Malaysia so long as it does not contain any caffeine, nicotinamide, paracetamol or poison within the meaning of the Poisons Act 1952 [Act 366]. In any event, upon importation, every traditional medicine or OTC product must still be registered in Malaysia through the standard registration process as provided in Regulatory Pricing and Reimbursement.

————————

Appendix 19 Labelling Requirement, Table 1, DRGD, NPRA, 3rd edn., January 2021
Controlled Medicine and OTC Medicine – What do they mean?, Medication General, MyHealth, MOH, at: http://www.myhealth.gov.my/en/controlled-medicine-and-otc-medicine-what-do-they-mean/
Table VI: Method of Evaluation According to Product Categories, DRGD, NPRA, MOH, 2016, revised Jan 2019.
Code of Conduct for Non Prescription (OTC) Products, Pharmaceutical Association of Malaysia (PhAMA), para 5.11.
Ibid. at para 5.12.
Ibid. at para 5.13

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Also from this Legal Handbook

6. Marketing, Manufacturing, Packaging & Labeling, Advertising: Malaysia

All about marketing, manufacturing, packaging & labeling, advertising in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

Although it is common for the marketing authorisation of medicines and devices to vest in the PRH, this is not necessarily the case. Where the party marketing the product and the PRH are two different person(s) or companies, the PRH will still be responsible for all aspects of the product, including quality and compliance with the conditions of marketing authorisation.¹

According to the CDCR 1984, once a product is registered any company intending to manufacture, import or wholesale such products need to have a valid manufacturing licence, import licence and wholesale licence respectively. The relevant licences for purposes of authorising any marketing of registered products in Malaysia would be the wholesaler’s licence which authorises the licensee to sell these products and devices by wholesale or supply the registered product from the address of the business premises specified in the licence.

2. What is the authorization process for the marketing of generic versions of these products?

Please refer to Question 6 of Regulatory, Pricing and Reimbursement regarding the authorisation process of marketing generic drugs.

3. What are the typical fees for marketing approval?

Given that the PRH would pay for the fees incurred in registering the product and the person(s) or company registering any medical devices would incur fees for obtaining an establishment licence, the fees for obtaining marketing approval will be the additional cost of obtaining the wholesale licence. The processing fee for an application of a wholesale licence is RM500.00, which is the same for import licences whereas the fee for manufacturing licence is RM1,000.00.

4. What is the period of authorization and the renewal process?

Refer to Question 5 of Regulatory, Pricing and Reimbursement, in particular, the section on Additional Licences.

5. What are the requirements, if any, for post-approval pharmacovigilance?

All PRHs must ensure that a pharmacovigilance system is in place by the person(s) or company and if necessary, that appropriate action is taken. Such compliance requires a PRH to have at its disposal, an appropriately qualified person responsible for pharmacovigilance activities. The role of this qualified person includes submitting relevant safety information including post-registration study reports and risk management plans (“RMP”) (a pharmacovigilance document).²

PRHs are also required to comply with all safety-related directives issued by NPRA. In doing so, all PRHs are responsible for producing a risk management plan which may include the views and recommendations of pharmacovigilance experts.

6. Are foreign marketing authorizations recognized?

Foreign marketing authorisations are not recognised – foreign companies must engage an Authorised Representative (AR) in Malaysia to register a product or device. The AR will then be the PRH for the relevant product. In order to market the product either the PRH or another person(s) or company must have a Malaysian wholesaler’s licence in order to sell the product at a specific place of business.

7. Are parallel imports of medicines or devices allowed?

Any person(s) or company intending to import medicine or devices into Malaysia requires an import licence and all such imports must be registered and imported by a person who holds the appropriate licence. The DCA may require any person(s) or company applying for the registration of imported products to furnish a written declaration made by or on behalf of the manufacturer of the imported product that all requirements imposed by the law of the manufacturer’s country governing the manufacture of the product have been complied with.

Medicines

Parallel imports for medicines are permitted so long as an AR is appointed and the product is properly registered. Each product that is imported must be registered with NPRA. See Question 6 of Regulatory, Pricing and Reimbursement above.

Medical Devices

Parallel imports for medical devices are not permitted as one product can only be registered with one AR or one manufacturer.

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

Healthcare professionals are prohibited from accepting any financial benefit or benefit-in-kind (including grants, sponsorships, scholarships, subsidies, support, consulting contracts, or educational or practice related items) in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so. Gifts that would inappropriately influence the prescribing practices of a healthcare professional would be prohibited (such as sporting or entertainment tickets, electronic items, social courtesy gifts, etc.)³

Permitted items:

Donations for charitable purposes to charitable organisations;
Grants to support educational programmes so long as they are unsolicited, from an institution organisation, unrelated to prescribing, purchasing, registration of any products, substantiated by written documentation of details of programme and able to withstand public scrutiny;
Informational or educational items provided to enhance patient care not exceeding RM1,500.00 per year per institution or healthcare professional; and
Items of medical utility provided by member companies not exceeding RM500.00 per item per healthcare professional. These items must not offset routine business practice and are beneficial to enhancing the provision of medical services and patient care.

Criminal Penalty

Offering and/or accepting a gratification corruptly for the purposes of inducing or rewarding any act or for showing forbearing to favour or disfavour any person in the course of carrying on business would amount to a criminal offence and upon conviction, such persons could be liable to imprisonment for a term up to twenty (20) years and a fine not less than five (5) times the sum or value of the gratification if it is capable of being valued or alternatively, ten thousand ringgit (RM10,000.00), whichever is higher.

9. How is the manufacturing of medicines and devices regulated and by which agencies?

Manufacturing of medicines and devices are generally regulated by NPRA. However, approvals for manufacturing activities must also be obtained from the Ministry of International Trade and Industry (MITI) and other Federal Agencies (such as the Department of Occupational Safety and Health (DOSH)).⁴ Further, manufacturers must obtain a manufacturing licence and comply with the International Good Manufacturing Practice (GMP) and Quality Assurance Programmes.

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?

Yes, they are compatible. Please refer to question 6 of Regulatory, Pricing and Reimbursement above.

11. What is the inspection regime for manufacturing facilities?

Manufacturers of registered products in Malaysia must provide acceptable evidence that the manufacturing premises conform to current GMP requirements – this includes foreign manufacturers who are also subject to GMP conformity assessments through inspections.

The application for a foreign GMP inspection should be made by a Malaysian PRH acting on behalf of the foreign manufacturer. The PRH shall then authorise a responsible person (i.e. Chief Executive Officer, Managing Director or Regulatory Manager) to act as the liaison officer with NPRA for all arrangements pertaining to the proposed inspection. Upon submission of relevant documentation by the appointed liaison officer, payment of the processing fee and inspection fee, the inspector will then travel to the foreign manufacturing site.⁵ The outcome of the GMP inspection will be tabled to the Committee of Evaluation of Inspection on Premises (“the Committee”). The Committee will then issue a report to the manufacturer through the applicant within 20 working days.⁶ The manufacturer is also required to submit a Corrective Action and Preventative Action (“CAPA”) report to NPRA within 30 days of receiving the GMP inspection report. All CAPA must be closed out within 6 months from the date the inspection report is issued.

If the GMP compliance is concluded as ‘acceptable’, the applicant can apply for a GMP certificate to the manufacturer through the applicant and this certificate can then be used for product registration/re-registration/change of manufacturing site with NPRA. If the GMP compliance is concluded as ‘unacceptable’, there is no further consideration or appeal for the GMP compliance of the manufacturer and a new application to NPRA for another inspection on the manufacturing facility must be made.

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Whilst it is mandatory that the NPRA have access to all local manufacturing facilities for the purpose of inspection, manufacturers also have the discretion to allow inspection by other foreign or third-party inspectors.

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Medicines/Products such as Health Supplements, Natural Products/Traditional Medicines and Non-Schedule Poisons (category T, N and X) are permitted to be shrink wrapped,⁷ whereas all Scheduled Poisons and medicines/products which contain Scheduled Poisons/ingredients must be stored, packaged and handled as follows:

The storage of any poison must be in a container impervious to the poison and sufficiently stout to prevent leakage from the container arising from the ordinary risks of handling. If the poison is kept for sale, whether by wholesale or retail or for dispensing purposes, it must be kept as such: –

in an unbroken case or package as received from the manufacturer; or
in a container tied over, capped, locked or otherwise safely secured in a manner different from that in which the container of non-poisonous substances kept in the same warehouse shop or dispensary are secured; or
in a container readily distinguishable by touch from all containers holding non-poisonous substances; or
in a container readily distinguishable by touch from all containers holding non-poisonous substances; or
in a room or cupboard under lock and key set apart from the keeping of poisons;

Where the poison is stored in any dispensary, retail shop or premises used in connection with the poison, it must be stored as such: –

in a cupboard or drawer under lock and key reserved solely for the storage of poisons, or in a part of the premises which is partitioned off or otherwise separated from the remainder of the premises and to which customers are not permitted access; and
if it is a liquid, to be kept in a container holding 2.5 litres or less, in a container which shall be readily distinguishable by touch from all containers holding non-poisonous liquids.⁸

Further, there is also a Guideline on Good Distribution Practice:

This guideline is used as a standard to justify status and as a basis for the inspection of facilities, such as manufacturers, importers and wholesalers. All manufacturers, importers and wholesalers of registered products / notified cosmetics and its related materials are required to adopt proper distribution and store management procedures appropriate for the distribution and storage of registered products / notified cosmetics and its related materials destined for the consumer. These procedures should include the management of personnel, premises, facilities and adequate documentary procedures that preserve the safety and quality of the material or product or cosmetic.

Good Distribution Practice or GDP is defined as: “The measures that need to be considered in the storage, transportation and distribution of any registered product / notified cosmetic and its related materials such that the nature and quality intended is preserved when it reaches the consumer”

14. What information must be included in medicine and device labeling?

The general requirements for a label of a product on its outer carton, immediate container or blister/strips are as such: –

product name;
dosage form;
name of active substance(s);
strength of active substance(s);
batch number;
manufacturing date;
expiry date;
route of administration;
storage condition;
country’s registration number;
name and address of PRH;
name and address of manufacturer;
warnings and/or specific labelling (if applicable);
pack sizes (unit/volume);
name and content of preservative(s) where present;
name and content of alcohol where present;
to declare source of ingredients derived from animal origin (active and excipient) including starting materials and gelatine;
to declare the source of capsule shell (if applicable);
recommend daily allowance (RDA) for vitamins/multivitamins/minteral preparations u sed as dietary supplements (optional);
the words ‘keep medicine out of reach of children’ or words bearing similar meaning in both Bahasa Malaysia and English;
other country specific labelling requirements (if applicable);
the words “controlled medicine/ubat terkawal” (for scheduled poison only); and
security label (hologram).⁹

The information on labels for medical devices should include: –

its Malaysian registration number (within 6 months from the date of the registration of the device);
details of the medical devices (including name and model);
batch code/lot number or the serial number;
indication of date until when the medical device may be used safely, expressed as the year and month;
name and contact details of the manufacturer and AR on the labelling;
technical details concerning the medical device;
description and intended use of the medical devices;
instructions for use of the medical device;
any undesirable side-effects, limitation, warnings and/or precautions on the safe use of the medical device;
any necessary post-marketing servicing needs for the medical device; and
any decommissioning or disposal information.¹⁰

15. What additional information may be included in labeling and packaging?

The label on medicines (poisons under Regulation 12 of the Poisons Regulation 1952) should include:

the name and address of the supplier or seller;
name of patient or purchaser;
name of the medicine;
adequate directions of use of such medicine;
date of delivery of such medicine;
where such medicine is sold or supplied and entered in a prescription book, with reference to the serial number of the entry in such book relating to such sale or supply.¹¹

When a poison or medicine containing any poison is sold or supplied as a dispensed medicine for external use, the container must be labelled conspicuously and distinctly with the words “Not to be taken” or “For external Use Only” in English, Malay, Chinese and Tamil printed in red or on a red background.¹²

For some medical devices the following specific contents must also be included on the labeling:

identification for a custom-made medical device and a statement that it shall only be used by a qualified practitioner for patient under his care;
an indication on the external packaging of any special storage and/ or handling conditions that applies;
verification that a medical device has been properly installed and can operate correctly and safely, the nature and frequency of preventative and regular maintenance, replacement of consumable components, and calibration needed to ensure optimal and safe operation of a medical device;
further treatment or handling, such as sterilisation, calibration, etc., that is needed before a medical device can be used;
identification for a sterile medical device, its indication for sterility and precautions and instructions if the sterile packaging is damaged, and where appropriate, description of re-sterilisation methods;
the requirement for sterilisation of a medical device before it is used and instructions for cleaning and sterilisation processes;
identification for a single-use medical device;
identification for a reusable medical device, information and instruction for cleaning, disinfecting, packaging and, where appropriate, the method of resterilisation, and any restriction on the number of reuses;
If the device is intended for research use only, it must be labelled as “research use only”;
sufficient details to obtain a safe combination for a medical device that is to be installed with or connected to other medical devices or equipment or with dedicated software, in order to operate as required for its intended purpose;
particular risks in connection with implantation of an implantable medical device;
the risks of reciprocal interference posed by a reasonably foreseeable presence of a medical device during specific investigation or treatment;
the details of the nature, type, intensity and distribution of the radiation emitted by radiation emitting medical device;
indication that the medical device is refurbished medical device. The refurbishment date shall also be indicated.¹³

16. What items may not be included in labeling and packaging?

All labelling for medical devices should exclude any statement, whether directly or indirectly, that the placement in the market or usage or operation of the medical device is being promoted or endorsed by the Authority or MOH or of its organisational bodies.¹⁴ Visuals, graphics and statements are prohibited on labels such as: –

marketing strategies (i.e. “money back guarantee”/“buy 1 free 1”/etc.);
bundling tactics (i.e. upon consuming Product A, for better result it is recommended that users take Product B);
consumer testimonies;
clinical trial results;
religious references and opinion of prominent figures;
label design similar to that of another company;
introduction of founder/manufacturer;
certificates (such as logo with certification, nutritional claims with analysis cert. attached)
name/statement/logo/registered trademark which does not satisfy the specifications;
special technique used/superiority in ingredients;
pictures (such as gender symbol, graphics of internal organs, indecent pictures, graphics incoherent with the indication, highlighting unnecessary body parts, graphics of plants or animals which may cause confusion);
negative statements (i.e. “this product is GMO/LMO free”/”free from preservatives”/etc.).¹⁵

This is not an exhaustive list and the Authority reserves the right to disallow other words, phrases or graphics for label which it opines to be misleading, improper or not factual.

Small labels (5ml and less) used for ampoules/cartridge, vial, eye drops, ear-drops and nose drops are exempted from the requirements in Question 14 above.

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

Medicines

Medicine advertisements shall be examined in accordance with laws and regulations, in particular the Medicine (Advertisement and Sale) Act 1956. All advertisements referring to any articles which would be used as a medicine, an appliance or a remedy for the purpose of treatment must be approved by the Medicine Advertisements Board.¹⁶ Upon approval, a serial number will be given and must be displayed on the advertisement.¹⁷

The types of advertisements which are expressly prohibited are those listed in the Schedule of the Medicines (Advertisement and Sale) Act 1956 as well as those relating to the promotion of contraception among human beings or improving the condition or function of the human kidney or heart or improving the sexual function/performance of human beings. and those relating to abortion or the skill or service of the advertiser.¹⁸

Medical Devices

Medical devices must be registered in accordance with the requirements of the Medical Device Act 2012 before it can be advertised. No person is permitted from making any misleading or fraudulent claims regarding medical devices in any advertisement. There is currently no enactment in Malaysia regulating the advertisement of medical devices however the MDA has prepared a Draft Code of Advertisement for Medical Devices with the aim to help the industry and healthcare professionals navigate this area in accordance with the Medical Device Act 2012.¹⁹ Under the Code, an application for medical device advertisement approval to the MDA shall be made for advertisements relating to:

home use medical devices; and
advertisement aimed for the general public

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicines

Any registered products i.e. medicines and poisons, may be sold and delivered in any manner in Malaysia. Poisons such as those listed in the Poisons List may be imported into Malaysia by letter or parcel post for personal use, including a prepared or packed medicine containing poison(s). This can be done not more often than once a month and not exceeding at any one time, the quantity required for one month’s use by one person.

Medical Devices

All medical devices must comply with the Good Distribution Practice for Medical Device (GDPMD) which was implemented pursuant to the Medical Device Regulation 2012. GDPMD specifies the requirements for a quality management system to be established, implemented and maintain when carrying out the activities in the medical device supply-chain to comply with the Malaysian medical device regulatory requirements as stipulated in Medical Device Act 2012. The certification to GDPMD is to be conducted by the registered conformity assessment body.²⁰ Once the GDPMD is complied with, devices can be sold and delivered through any method, including post.

19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?

Statutory requirements for drug advertising equally apply to marketing medicinal products on the internet. For instance, medicine providers over the internet would still require the necessary licences and approvals i.e. wholesaler’s licence in order to sell medicines and medical devices. All advertisements must be approved by the Medicines Advice Board (“MAB”) and the approval number obtained must be displayed on the published advertisement.²¹ The prohibitions on advertising (see question 17 above) would still apply to e-marketing and advertising via the internet. The duty is on the web advertisers to ensure that the materials posted on the internet do not contravene any regulations. ²²

20. May medicines and devices be advertised or sold directly to consumers?

In Malaysia scheduled poisons i.e. prescription drugs meaning those that can be obtained following a prescription from a doctor are prohibited from being advertised openly to the public in any media including social media and the internet. However, some exceptions are made for information advertised by the government or information which would be relevant to parties such as doctors, pharmacist, nurses and members of the local authority or the governing body of a hospital.²³

21. How is compliance monitored?

Medicines

The NPRA undertakes regular check-ups on any local and foreign manufacturing companies to ensure that such manufacturers are compliant with the guidelines, rules and regulations issued by the NPRA. This review is also done at the stage of licence renewals by the manufacturers.

Medical Devices

Under the Code of Advertising for Medical Devices the responsible person (i.e., manufacturer or authorised representative of the medical device) may assign advertisers consisting of private individual or any third party, to advertise the medical device on their behalf, and ensure compliance with regulatory requirements.

22. What are the potential penalties for noncompliance?

Medicine

Any contravention of the restrictions stated in Question 17 above may result in a criminal offence and the offender may be liable to summary conviction which would result in a fine not exceeding RM3,000 or to imprisonment for a term not exceeding one year or to both. Following any subsequent convictions, the offender may be liable to a fine not exceeding RM5,000 or to imprisonment for a term not exceeding two years or to both.

Medical Device

Any contravention of advertising as against the provisions of the Medical Device Act 2012, would result in the commission of an offence and the offender shall, on conviction, be liable to a fine not exceeding three thousand ringgit (RM3,000) or to imprisonment for a term not exceeding three years or to both.

Drug Registration Guidance Document (DRGD), National Pharmaceutical Regulatory Division (NPRA), Ministry of Health (MOH), 3nd edn., 2021
Malaysian Pharmacovigilance Guidelines, NPRA, MOH, 2nd edn., 2016.
PhAMA Code of Pharmaceutical Marketing Practices, For Prescription (Ethical) Products, Pharmaceutical Association Malaysia, 21st edn., 2019, para 2.4 and 7.6.
Guide on Pharmaceutical Industry in Malaysia, MIDA, 2018 edn.
Guidance Document Foreign GMP Inspection, NPRA, 7th edn, 2021 paragraph 6.9
Ibid. at paragraph 6.17
NPRA, MOH, General Conditions For Registration Of Drug Products Under The Control Of Drugs And Cosmetics Regulations 1984, Jauze, 2018, para 6.3.1. https://www.npra.gov.my/index.php/my/general-conditions-for-registration-of-drug-products-under-the-control-of-drugs-and-cosmetics-regulations-1984.html
Regulation 6 of the Poisons Regulation 1952.
Appendix 9, Table 1 at 9.1 General Labelling Requirement, DRGD, NPRA 3rd edn, 2021
Medical Device Guidance Document, Requirement for Labelling of Medical Devices, MDA, MOH, November 2018, 3rd edn, pg. 4 – 6, para 4.1(b) and 4.8.
Regulation 12, Poison Regulation 1952 P.U.(A) 330/2018.
Ibid.
Ibid. at pg. 6 and 7, para 4.9.
Ibid. at pg 4, para 4.1(c).
Appendix 6, Drug Registration Guidance Document (DRGD), NPRA, 3rd Edition, January 2021 MOH, , pg –29-31
s.4B of the Medicines (Advertisement and Sale) Act 1956.
Press release by the Director General of Health, Beware of Illegal Advertisement, Official Portal of Pharmaceutical Services Programme, MOH, 2012 at https://www.pharmacy.gov.my/v2/en/news/04-dec-2012/beware-illegal-advertisements.html
S.3, s.4, s.4A of the Medicines (Advertisement and Sale) Act 1956.
Certification. Medical Only., Malaysia: Code on Advertisement for Medical Devices at https://www.med-cert.com/malaysia-code-on-advertisement-for-medical-devices/
Good Distribution Practice for Medical Devices (GDPMD), Regulatory Requirements for Medical Device Safety & Performance, 1st revision, 2015 at: https://www.mdb.gov.my/mdb/index2.php?option=com_docman&task=doc_view&gid=817&Itemid=59
Risk of purchasing medication via Internet, Official Portal of Pharmaceutical Services Programme, MOH, 2015, at https://www.pharmacy.gov.my/v2/en/content/risk-purchasing-medications-internet.html
Medicines Advertising in Pharmaceutical Industries, My Health, MOH.
Advertisement of Prescription Medicines, MyHealth, MOH.

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7. Preclinical & Clinical Trial Requirements: Malaysia

The low-down on the situation regarding preclinical & clinical trial requirements in Malaysian pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

Malaysia is actively developing its capability in all phases of clinical trials and there is currently no mandatory condition for clinical trials to be conducted locally. However, where drugs are imported into Malaysia for the purpose of clinical trials a Clinical Trial Import License (“CTIL”) is required and where the drug intended to be manufactured in Malaysia solely for producing samples for clinical trials or for registration, a Clinical Trial Exemption (“CTX”) is required.

In addition, as an ASEAN member nation, Malaysia has adopted the ASEAN Guideline for the Conduct of Bioavailability/Bioequivalence Studies. Accordingly, in addition to the CTX, a bioequivalence study (BE) report must be produced for any generic medicine for certain categories of oral immediate release products, including those containing active ingredients which have been previously approved and/or product information which have been previously approved and/or route of administration, strength and dosage form equal to those of products which have been previously approved.

2. How are clinical trials funded?

The Malaysian Ministry of Science, Technology and Innovation (MOSTI) is tasked with providing four (4) research funds including ScienceFund, TechnoFund, InnoFund and Flagship Programme. The TechnoFund is granted for technology developments up to pre-commercialisation stage and the InnoFund is granted for the development or improvement of new or existing products, processes or services with elements of innovation. The Scope of funding for these two initiatives include pre-clinical and clinical testing/trial. In addition, the Clinical Research Malaysia (CRM), a wholly government-owned non-profit organisation under the MOH was established to develop infrastructure for Clinical Research Centre networks and to support global industry sponsored research (ISR) requirements. The CRM is authorised by the Malaysian government to act as a trustee in managing the budgets of clinical trials conducted in the country by receiving and executing its disbursements.

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

Drugs

The single regulatory authority in Malaysia that regulates clinical trials and the licensing scheme for clinical trials is the NPRA.¹ The National Committee for Clinical Research adopted ICH E6 Good Clinical Practice into the Malaysian Guideline for GCP to facilitate the mutual acceptance of clinical data that are intended to be submitted to regulatory authorities. Therefore, all those involved in clinical trials must comply with the international ethical and scientific quality standard and obtain a Good Clinical Practice (“GCP”) certification.² The trial should be conducted in accordance with a protocol agreed upon by the sponsor and, if required by the regulatory authority(ies) and which was given approval/favourable opinion by an Institutional Review Board/Independent Ethics Committee (IRB/IEC). The investigator/institution and the sponsor should sign the protocol or an alternative contract to confirm the agreement.³

In addition, the investigator/institution is required to fill in and submit a proposal template(s) and a Checklist for Clinical Trial Protocols Involving Human Subjects and Generating Data Intended to be submitted to Regulatory Authorities.⁴ Furthermore, before commencing any clinical trial involving product(s) requiring a CTX/CTIL and prior importation/manufacturing product locally for the study, the investigator/sponsor must submit an application for a CTIL/CTX to the NPRA.⁵

Medical Device

Before medical devices are used for the purposes of clinical trials, so long as it is imported into or manufactured in Malaysia it must be registered (or be exempted under the Medical Device (Exemption) Order 2016). The relevant body from which approval must be sought is the MDA. In order to apply for the exemption a notification must be submitted to the MDA who will then issue a No Restriction Letter for the lawful supply of the medical device for any specific use.⁶

4. What are the requirements for consent by participants in clinical trials?

The investigator must obtain and document the informed consent from the subjects of the clinical trials and in its efforts, should adhere to the GCP and ethical principles originally found in the Declaration of Helsinki. Before commencing the trial, the investigator should have the IRB/IEC’s written approval/favourable opinion of the written informed consent form and any other written information provided to the subjects. Further, any revised written informed consent form, and written information should receive the IRB/IEC’s written approval/favourable opinion in advance of any usage. The subject or the subject’s legally acceptable representative should be informed of new information which may be relevant to the subject’s willingness to continue participating in the trial. The communication of this information should be documented.

The subject or the subject’s legally accepted representative should be informed of all pertinent aspects of the trial and be given ample time and opportunity to inquire about the details of the trial and have all questions answered to his/her satisfaction. The written informed consent form should be signed and personally dated by the subject or by the subject’s legally acceptable representative, and by the person who conducted the informed consent discussion.⁷

5. May participants in clinical trials be compensated?

During the informed consent discussion and when filling in the written informed consent form and any other written information, an explanation on the compensation and/or treatment available to the subject, in the event of a trial related injury, should be included.⁸ It is the responsibility of the IRB/IEC to obtain information about the payments and compensation available to subjects.⁹

If required by the applicable regulatory requirement(s), the sponsor should provide insurance or indemnity the investigator/institution against claims arising from the trial save for those arising from malpractice and/or negligence.¹⁰

The sponsor should obtain from the investigator/institution the following: –

the name and address of the investigator’s/institution’s IRB/IEC
statement obtained from the IRB/IEC that it is organised and operates according to GCP and the applicable laws and regulations.
documented IRB/IEC approval/favourable opinion and, if requested by the sponsor, a current copy of the protocol, the written informed consent form(s) and any other written information to be provided to the subjects, the subject recruiting procedures, documents related to payments and compensation available to the subjects, and any other documents that IRB/IEC may have requested.¹¹

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

If required by the applicable regulatory requirement(s), the sponsor ought to provide insurance or should indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial except for claims that arise from malpractice and/or negligence. Given that the participants would sign a Clinical Trial Agreement giving their informed consent to participate, unless harm arises as a result of malpractice and/or negligence, participants would have to rely on personal medical insurance in case of other unforeseen events.

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NPRA, MOH website, 02.07.2015 https://www.npra.gov.my/index.php/en/about/addons-list-6/roles-and-functions.html; Baker McKenzie, Clinical Trials Handbook Asia Pacific, Chew and Lew, Malaysia.
NPRA, MOH, Malaysian Guideline for Good Clinical Practice, adapted from the ICH E6: Good Clinical Practice, 4th edn, 2018, pg. 8; Society of Clinical Research Professionals Malaysia, A Guide to Conducting Clinical Trials in Malaysia, 1st edn, 2016, pg. 13.
Ibid. pg. 28
Institute for Clinical Research, Clinical Research Malaysia, Clinical Research Documents, 1. Research Protocol/Proposal.
Society of Clinical Research Professionals Malaysia, A Guide to Conducting Clinical Trials in Malaysia, 1st edn, 2016, pg. 25-28.
Notification for Exemption from Registration of Medical Devices for the purpose of clinical research or performance evaluation, Medical Devices Guidance Document, MDA, 1st edn. 2017 at https://portal.mda.gov.my/index.php?option=com_docman&view=download&alias=556-mdagd0016-notification-for-clinical-research-or-performance-evaluation&category_slug=guideline-documents&Itemid=476
NPRA, MOH, Malaysian Guideline for Good Clinical Practice, adapted from the ICH E6: Good Clinical Practice, 4th edn, 2018, pg. 30.
Ibid. pg. 31.
Ibid., 3.1.2 Responsibilities, pg. 22.
Ibid. pg. 41.
Ibid., 5.11 Confirmation of Review by IRB/IEC, pg. 42.

Click the following links to read more legal articles from Malaysia:

Also from this Legal Handbook

8. Regulatory, Pricing and Reimbursement: Malaysia

An intro to the legal situation for regulatory, pricing and reimbursement in Malaysia. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GDP 99.

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The Ministry of Health (MOH) is the primary governmental body responsible for the health of the people and the overall healthcare system in Malaysia. Its key governmental agencies responsible for the administration of drugs and medical devices are as follows:

National Pharmaceutical Regulatory Agency (NPRA), formerly known as the National Pharmaceutical Control Bureau (NPCB), is tasked with implementing quality control on pharmaceutical products and meeting the requirements for testing and quality control activities. NPRA also implements and manages regulatory, licensing and product recall schemes as well as carries out research on methodology and training for pharmaceutical and professional officers.¹
Drug Control Authority (DCA) regulates combination products and is tasked with ensuring the safety, quality and efficacy of pharmaceuticals, health and personal care products marketed in Malaysia. The DCA oversees the registration of pharmaceutical products and cosmetics, licensing of premises (for importers, manufacturers and wholesalers) and monitoring the quality of registered products and Adverse Drug Reactions (ADR).²
Malaysian Adverse Drug Reaction Advisory Committee (MADRAC) is established under DCA to carry out pharmacovigilance for registered drugs in Malaysia. All ADR reports received and assessed by MADRAC are forwarded to central World Health Organization (WHO) Global ICSR database. MADRAC works to promote ADR reporting in Malaysia and provide reliable information and advice to DCA, doctors, pharmacist and other healthcare professionals on drug safety.³
Medical Device Authority (MDA) controls and regulates medical devices in accordance with the Medical Device Act 2012 for registration of the medical devices, issuance of licences, training and awareness. The MDA also issues licences to establishments who import, export and place medical devices in the Malaysia market, surveillance and vigilance of medical devices and usage of medical device.⁴
Malaysian Pharmaceutical Services Programme (Pharmaceutical Divi-sion), is the enforcement agency of the MOH responsible for ensuring that safe, efficacious and quality pharmaceutical products are made available to the public, protecting their interest via enforcement of relevant legislations and ensuring rational use of medicines by both healthcare providers and patients.

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

DRUGS

Key Legislation

The key legislations for the drug industry in Malaysia are the Sale of Drugs Act 1952, Dangerous Drugs Act 1952, Poisons Act 1952, Medicines (Advertisement and Sale) Act 1956, and the Control of Drugs and Cosmetic Regulations 1984. Other guidelines and regulations issued by NPRA have also be implemented to provide guidance to the pharmaceutical industry.

Authorization

The drug formulary produced by the MOH contains a list of drugs that has been approved by the MOH hospitals and institutions. Prior authorization and approval by the Director-General of Health is required before the use of any non-formulary drugs. In order to obtain approval for a new drug, an application must be approved in accordance with the following steps: –

Pre-submission of application: the category of product, method of evaluation and requirements for product registration must be determined;
Submission of application: applicant must register and submit application via the online QUEST3 system;
Screening of application: initial valuation carries out to ensure the required data/information of the submitted application are complete. This takes place before payment is made;
Evaluation of application: Application with the submitted data is evaluated following different categories of products and/or level of claims. Applicant shall be informed via the system if any further supplementary data/information or documentation is deemed necessary by the Authority. Application is rejected if there is no response to the correspondence from NPRA within six (6) months from the first correspondence date. This takes place after payment is made;
Regulatory outcome: a regulatory decision will be sent via email/official letter to the product registration holder. The Authority may, at any time reject, cancel or suspend the registration if there are deficiencies in safety, quality or efficacy of the product or failure to comply with conditions of registrations. A product registration number shall be assigned to the registered product.
Post-registration process: registration status shall be valid for five (5) years or a period as specified in the Authority database. Upon approval, the application shall fulfil all commitments and conditions imposed during the approval process and shall be responsible for the maintenance of the product in terms of quality, safety and efficacy throughout the validity of the registration period.

BIOLOGICALS

The specific requirements for registration of biologicals are set out in the

Guideline on Registration of Biologics. This comes under Appendix 4 of the Drug Registration Guidance Document (DRDG)

The requirements for registration of biologics/ biopharmaceuticals shall be in accordance to the ASEAN Common Technical Dossier (ACTD) format and in adherence to the general regulatory requirement as described in sections of the main DRGD.

It covers:

Administrative information
Product quality data
Product safety data
Clinical data, demonstrating clinical efficacy and capacity to meet therapeutic claims, through clinical studies
Biologics include a wide range of products such as:

Vaccines;
Blood products;
Monoclonal antibodies (therapeutics);
Recombinant proteins:

- Insulins
- Hormones
- Erythropoetins and other hematopoietic factors
- Cytokines: interferons, interleukins, colony-stimulating factors, tumour necrosis factors

5. Cell and Gene Therapy Products (CGTPs)

There are specific requirements which exist for the registration of different types of biologics under the DRGD. These include specific requirements for the registration of Vaccines, Biotechnology Products, and Blood Products.

Pricing

The MOH is the largest pharmaceutical spender and indirectly controls and reduces medicine price with bulk purchase. The three procurement methods are 1) Supply by Concession Company 2) National tender and 3) Local purchase.

There are no price control methods in the private sector. Manufacturers, distributors and retailers may offer any prices in the free market without any pricing policy or regulation. However, under the Pharmaceutical Services Programme (PSP), MOH have published and updated a Consumer Price Guide (CPG) as a public reference to purchase medicines in the private sector. The PSP have conducted studies and produced reports with the aim of guiding medicine pricing policy and improving accessibility and affordability of medicine in Malaysia.

Nonetheless, based on publicly available information, the MOH has plans to implement price control measures. The MOH is targeting single-source innovative drugs sourced through public procurement in its first phase of price controls by using external reference pricing to benchmark drug prices in Malaysia against eight to 12 countries. The average three lowest reference prices will then be chosen to determine the maximum medicine prices allowed in Malaysia at the wholesale and retail levels (clinics, hospitals, pharmacies). However, as of June 2021, this has yet to be implemented and the countries that will be used as part of the references have yet to be decided.

Reimbursement

There is currently no national reimbursement scheme in Malaysia. However, the CPG published by the Pharmaceutical Services Programme is said to provide a comprehensive and reliable price data for consumers and for insurance reimbursement until a systematic nationwide procurement and reimbursement scheme can be implemented.

MEDICAL DEVICES

Key Regulations

The key legislation for the medical device industry in Malaysia is the Medical Device Act 2012. The First Edition of the Medical Device Guidance Document and Licensing for Establishment produced by the MDA also provides guidance on licensing requirement and establishments dealing with medical devices in Malaysia, to ensure compliance with the Medical Device Act and regulation.

The Medical Device (Advertising) Regulations 2019 and Medical Device (Duties and Obligations of Establishments) Regulations 2019, which were gazetted by the Malaysian Parliament under the Medical Device Act 2012, have officially come into effect as of 1 July 2020.

The Medical Device (Advertising) Regulations 2019 prescribes the matters relating to the contents of and conditions for advertising of medical devices. Meanwhile, the Medical Device (Duties and Obligations of Establishments) Regulations 2019 prescribes the manner, criteria, conditions and procedures of post-marketing activity of medical devices.

Authorization

Medical devices must be registered before they can be used and sold in Malaysia by licensed establishments. In Malaysia, medical devices are classified into 4 risk classes, namely Class A (Minimal), Class B (Low to Moderate), Class C (Moderate to High) and Class D (High). Manufacturers must ensure that their products conform to Essential Principles of Safety and Performance (EPSP) and Good Manufacturing Practices (GMP) standards and that a Conformity Assessment Body (CAB) certification is obtained in order to receive MDA approval for their product registration application. Moreover, a medical device cannot be imported, exported, or placed on the market unless it is registered. A single producer or authorised agent can only register one medical device. Multiple registrations of the same product are not permitted.

The general procedure to register a medical device is to group and classify it in one of the classes abovementioned, following which, a Common Submission Dossier Template (CSDT) must be prepared (including technical information i.e. design input/specification/verification/etc.). Then, a conformity assessment is conducted and assessed by CAB. The manufacturer can then apply to register the medical device and MDA will conduct an evaluation thereafter. If approval is granted, the medical device will be registered upon payment of a prescribed fee.

Notwithstanding the above, in 2016, a Medical Device (Exemption) Order was gazetted which provides an exemption for registration required under the Medical Devices Act 2012 for the following purposes: –

the purpose demonstrating the marketing;
the purpose of education;
the purpose of clinical research or performance evaluation of medical device;
a custom-made medical device; or
a special access medical device.

An importer or manufacturers of the above-mentioned medical devices are also exempted from obtaining the required establishment licence. However, prior to any importation of a device potentially eligible for exemption, a notification must be sent by the manufacturer or importer to MDA.

Pricing

There are currently no laws regulating market prices for medical devices.

Reimbursement

There is no national reimbursement scheme for medical devices in Malaysia.

COMBINATION PRODUCTS

Key Legislation

The same as that which regulates drugs and medical devices separately. Aside from legislation, reference can also be made to the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products.

Authorization

There are different registration processes for combination products which are described as products comprising of two or more regulated components combined to produce a single entity i.e. drug/device, biological/device or drug/device/biological or two or more separate products packaged together in a single package or as a unit.

According to the 2020 Guideline For Registration Of Drug-Medical Device And Medical Device-Drug Combination Products: The registration process of Drug-Medical Device combination product hall undergo the following 2 stages:

Stage 2 – Obtaining Endorsement from MDA
Stage 3 – Application For Registration to NPRA

Note: All the stages shall be completed, with the exception of low risk medical devices which may proceed directly to Stage 2- Application for Registration to NPRA.

The registration process of Medical Device-Drug combination product shall undergo the following: –

Stage 2 – Obtaining Certification from CAB
Stage 3 – Obtaining Endorsement from MDA

3. What are the steps to obtaining authorization to develop, test, and market a product?

Refer to authorization in section 2 above.

4. What are the approximate fees for each authorization?

No.	Category of Product	*Processing Fees	Laboratory/Analysis Fees	Total Fees
1.	Pharmaceutical a) New Drug Products b) Biologics	RM 1,000.00	Single active ingredient: RM 3,000.00	RM 4,000.00
1.	Pharmaceutical a) New Drug Products b) Biologics	RM 1,000.00	Two or more active ingredients: RM 4,000.00	RM 5,000.00
2.	Pharmaceutical a) Generic (Scheduled Poison) b) Generic (Non-Scheduled Poison) c) Health Supplement	RM 1,000.00	Single active ingredient: RM 1,200.00	RM 2,200.00
2.		RM 1,000.00	Two or more active ingredients: RM 2,000.00	RM 3,000.00
3.	Traditional/Natural Product	RM 500.00	RM 700.00	RM 1,200.00

Certificate fees for any product where such certification is required by any country importing such a product

Certificates	Fee	Validity
Issuance of one (1) Certificate of Pharmaceutical Product	RM 50.00	2 years
Issuance of one (1) Certificate of Good Manufacturing Practice (GMP)	RM 50.00	2 years
Issuance of one (1) Certificate of Declaration (Sijil Deklarasi)	RM 50.00	–
Issuance of one (1) Certificate of Indication (Sijil Indikasi)	RM 50.00	–

Charges for Product Classification

Processing fee	Timeline
RM 300 per product for each application	7-14 working days upon receipt of complete and satisfactory application

Device Classification	Application Fee	Processing Fee
Class A	MYR 100	n/a
Class B	MYR 250	MYR 1,000
Class C	MYR 500	MYR 2,000
Class D	MYR 750	MYR 3,000
Combination device	MYR 750	MYR 5,000

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Drugs

Marketing registration for drugs is valid for a period of (5) years or such period as specified in the registration certificate. Renewal of the product registration shall be done no later than 6 months prior to expiry of the product registration. The product information/amendments/variation can be updated through a proper application. Any changes affecting the quality, safety and efficacy of a registered product cannot be renewed – a new registration shall be required. This is however not applicable to non-medicated and contraceptive devices.

Medical Devices

All establishments importing, exporting or placing on the market any registered medical devices must obtain an establishment licence. This licence is valid for three (3) years but may be renewed no later than one year before the expiry date by paying the prescribed fee and complying with any request for information, particulars or documents as may be required by the MDA.

Additional Licences

In addition to the product registration and establishment licence, any person(s) or company that intends to manufacture, import or wholesale any registered product will have to obtain a Manufacturer’s Licence, Import Licence or Wholesale Licence respectively. Each licence is valid for a period of one (1) year and an application must be submitted together with the following documents: –

a copy of Company/ Business Registration Certificate
a copy of Business License (Local Authority) for business premise or store (if any)
a copy of Applicant’s/License Holder’s Identity Card
a copy of Annual Retention Certificate and/or Type A License (This document is necessary if products manufactured/ imported/ wholesale are Scheduled Poison A products or any other products that require a Pharmacist)

Application for these licences must be made to the Drug Control Authority through the QUEST 3+ System. These licences are non-transferable. Compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) is required for the application of a manufacturing licence as well as product registration, whilst GDP compliance is required for the application of a wholesale or import licence.

For the renewal of any of these licences, a new application with the same supporting documents abovementioned must be submitted along with a copy of the previous licence.

6. How does the authorization process differ between brandname products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

All medicines, either brand-name (“the innovators”) or generic medicines must undergo a scientific evaluation process to establish their quality, safety and efficacy. Generic medicines must have specifications similar to that of the innovators to ensure they are equally effective and interchangeable. Both brand-name and generic medicines’ facilities must comply with the same standards of Good Manufacturing Practices (GMP). The regulatory requirements in Malaysia are similar to that of other developed countries.

Malaysia is a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Therefore, the code and standards of GMP is the same as that used by PIC/S members such as Australia, Canada, Europe and the United States. Local manufacturers however are subject to licensing and periodic GMP audits. Foreign manufacturers of imported generic medicines are also subjected to GMP conformity assessment whereby the manufacturers are required to provide acceptable evidence that the premise conforms to current GMP requirements. Where the GMP evidence is not available or the documents are insufficient or unsatisfactory to demonstrate equivalence to GMP standards, the DCA may require an on-site audit of the foreign manufacturer. In order to ensure that generic medicines comply with strict registration requirements, all registered generic medicines are subjected to post-market surveillance, complaints and adverse drug reactions monitoring programme.

Local manufactures must ensure that the products meet essential principles of safety and performance (EPSP) and are manufactured in accordance with GMP. Both local and foreign manufacturers must apply for registration of their medical device products. The process of registration of medical devices for foreign manufacturers are as such: –

A foreign manufacturer needs to appoint an Authorised Representative (AR) to register their devices;
The AR must prepare the registration application Common Submission Dossier Template (CSDT) based on the technical information from foreign manufacturer to be submitted to the MDA;
An independent CAB (different from the one engaged by the foreign manufacturer in other countries) is to review the same registration application dossier and issue a CAB certificate to be submitted to the MDA; and
The MDA will then review and approve or reject the registration of the medical device under the registration name of the AR for the device to then be marketed in Malaysia.

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

In Malaysia, the primary agency for registration of combination products is based on the primary mode of action/the principal mechanism of action by which the claimed effect or purpose of the product is achieved.⁵ In short, if the primary function of the combination product is as a drug, that would be its classification. Drug is based on pharmacological, immunological or metabolic action in/on the body.⁶ Combination products categorised as drug by the DCA is regulated in accordance with the CDCR 1984 and any other relevant documents published by NPRA.⁷

Medical devices do not achieve their primary mode of action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means.⁸ Combination products regulated as medical devices by the MDA is in accordance with the Medical Device Act 2012 and its subsidiary legislation, and any other relevant documents published by the MDA.

Additionally, any drug substances used as ancillary to medical device which is listed as a scheduled poison shall be regulated in accordance with the Poison Act 1952.⁹

8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Compliance with regulation is monitored by different agencies depending on the relevant products. Before any product is marketed and sold in Malaysia, it must be registered with the DCA even if it has received approvals from other regulatory bodies such as the US FDA.¹⁰ Furthermore, although the International Council for Harmonization (ICH) and European Medicine Agency (EMA) guidelines are generally acceptable in most ASEAN countries, there are additional regulatory requirements as well as enforcement and compliance procedures unique to Malaysia that must be further complied with for the dispensing and marketing of medicines.¹¹ These are set out in detail below.

The NPRA monitors compliance with regulations on drug related matters. Any pharmacy or individual carrying on the business of manufacturing, whole-selling and/or importing medicines in Malaysia must obtain the respective licences from the NPRA. Upon doing so, the NPRA will conduct various inspection on the premises of the business. In particular, a GMP inspection will be carried out for manufacturers and a GDP inspection for wholesalers and importers. This inspection may be carried out annually depending on the performance of the business. In undergoing the renewal process for each licence, all such manufacturers, wholesalers and importers must comply with the current regulations set out by the NPRA.¹² All validly licenced pharmacy or business will be listed on the NPRA website.

The Malaysian Pharmaceutical Division regulates any pharmacy dispensing or marketing medicines and products containing scheduled poisons, (chemicals listed in the First Schedule of the Poisons Act 1952) or non-scheduled poisons (chemicals not found in the First Schedule of the Poisons Act 1952). This body is tasked with enforcing compliance to existing legislation and ensuring that the link of supply and marketing, advertising of the products (including the medical services) and its usage are properly managed.¹³ In ensuring continued compliance with all the local legislative provisions, rules and guidelines, the Pharmaceutical Division would carry out its own annual inspection and audit for the renewal of any such licences granted.

9. What is the potential range of penalties for noncompliance?

Failure to submit necessary documentation and reports (i.e. BE studies) will result in a rejection of the application for registration of the product. Additionally, if the DCA finds unsafe or sub-standard medicines, they are authorised to remove such products from the market. According to the CDCR 1984 enforced pursuant to the Sale of Drugs Act 1952, as well as the Dangerous Drugs Regulations 1952, non-compliance by any persons (depending on the nature of the non-compliance) could lead to financial penalties, suspension of business activities, revocation of a product registration or establishment licence. Save in the more serious cases, violations of the legislation and regulations on drugs and medical devices may attract criminal liabilities, including imprisonment.

10. Is there a national healthcare system? If so, how is it administered and funded?

Malaysia has a two-tiered healthcare service sector: a government-based and publicly funded sector and a private sector. The public healthcare services are tax-funded and administered by the Ministry of Health through its central, state and district offices. The policies and programmes are centrally formulated, funded and administered. There are also many active non-governmental organisations providing emergency ambulatory and relief services in Malaysia.

11. How does the government (or public) healthcare system function with private sector healthcare?

To a small extent the MOH also regulates the private sector, i.e. requiring health care professionals to register with statutory professional bodies. In addition, the MOH also regulates the pharmaceutical industry and food safety offering comprehensive services ranging from preventive and primary health care to tertiary hospital care. The private health sector provides health services, mainly in urban areas, through physician clinics and private hospitals with a focus on curative care. The government also works with private insurance companies to give low-income people with cheap healthcare protection and coverage. For example, via the “mySalam National Health Protection Scheme”.

12. Are prices of drugs and devices regulated and, if so, how?

See Question 2 above regarding the regulation of price of drugs and device products.

13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?

Malaysia’s public health system is financed mainly through general revenue and taxation collected by the Federal government, while the private sector is funded through private health insurance and out-of-pocket payment from consumers.

Government taxes collected by the Treasury are allocated to the MOH under the framework of five-year plan and annual budgets. The MOH funds its public health care facilities through global budgets based on historical spending, while the private sector funders mainly seek fee-for-service to pay for their facilities and expenditure.

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Medicines are dispensed by registered medical practitioners, registered dentists and registered veterinarians. Medicines and devices are dispensed by hospitals and pharmacists. Public hospitals are government funded and are therefore compensated by taxpayers whereas pharmacists tend to be privately owned and therefore are paid out-of-pocket of consumers.

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

Pharmacists are regulated by the Malaysian Pharmaceutical Society (MPS) and must adhere to a code of conduct therefore maintaining the highest professional standard in the discharge of their professional service to patients and clients, in their conduct and professional relations with members of the profession and other allied professions. Various extensive guidelines are available concerning good dispensing practices. These include the “Guidelines for Good Dispensing Practice” adopted by the Malaysian Medical Council on 19 July 2016 and the “Guide to Good Dispensing Practice” issued by the Pharmaceutical Services Division of the Ministry of Health Malaysia in 2016

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(1) NPRA, MOH website, 02.07.2015 https://www.npra.gov.my/index.php/en/about/addons-list-6/vision-mission-and-objective.html
(2) NPRA, MOH website, 03.07.2015 https://www.npra.gov.my/index.php/en/about/drug-control-authority-dca/about-the-dca
(3) NPRA, MOH website, 20.03.2019 https://www.npra.gov.my/index.php/en/about/malaysian-adverse-drug-reactions-advisory-committee-madrac/madrac-introduction
(4) MDA, MOH official portal, background pg. https://portal.mda.gov.my/introduction/background.html
(5) Ibid. pg. 10
(6) Ibid. pg. 10.
(7) Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products, MOH, 1st edn, 15th March 2017, https://www.npra.gov.my/images/Guidelines_Central/MDC/Garis_Panduan_13.3.17.pdf, at pg 2
(8) Ibid. pg. 10
(9) Ibid. pg. 2.
(10) NPRA, MOH, Frequently Asked Questions (FAQs) Veterinary Medicine, question 2), https://www.npra.gov.my/index.php/en/frequently-asked-questions-faqs-veterinary-medicine/general-regulatory.html
(11) Regulatory Affairs Professional Society, Regulatory Focus, News Article, The drug regulatory landscape in the ASEAN region, 2018 https://www.raps.org/news-and-articles/news-articles/2018/1/the-drug-regulatory-landscape-in-the-asean-region
(12) NPRA, MOH, Frequently Ask Question: Compliance and Licensing, question 1), 5) and 11), https://www.npra.gov.my/index.php/en/faqs-compliance-and-licencing/frequently-asked-questions-faqs-licensing.html?highlight=WyJmcmVxdWVudGx5Il0=
(13) Pharmacy Enforcement Division, Official Portal of Pharmaceutical Services Malaysia, MOH, 2018, https://www.pharmacy.gov.my/v2/en/content/pharmacy-enforcement-division.html