Tagged with Regulator

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? In Brazil, CONITEC is the main HTA evaluation body, which is responsible for recommending the incorporation of health technologies…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Are there any Managed entry agreements in place in your country? (If so, please list them) The first public and only managed access agreement reported in Brazil was signed between the Ministry of Health…

Switzerland For the Swiss Agency for Therapeutic Products (Swissmedic), one of the world’s leading regulatory authorities, 2023 was an important year. Not only did the agency gain recognition from the World Health Organisation (WHO), Swissmedic also saw a Good Manufacturing Practice (GMP) agreement between Switzerland and the US FDA come into…

India The State of Gujarat is one of India’s most culturally diverse, the birthplace of ‘Father of the Nation’ Mahatma Gandhi, and the only place in the world where Asiatic lions can be found in their natural habitat. It is also an economic powerhouse, with key Gujarati industries including dairy, cement,…

USA The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) approved no less than 55 new drugs in 2023, a number surpassing that of 2022 by almost 50 percent. While 28 rare disease treatments and five novel gene therapies got the green light, the agency also…

Japan Toshi Tominaga of Keio University Hospital, writing in the January 2023 edition of the DIA Global Forum magazine, outlines some recent updates to Japanese drug registration legislation, including how domestically generated academic clinical data can be utilised.   Japan’s current regulatory framework for investigator-initiated trials (IITs) of drug candidates seems…

Brazil Brazil’s ANVISA is commonly recognised as LatAm’s leading national medicines regulator and is defined by the Pan American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference (NRAr) for medicines and vaccines. As part of our Transformative 2023: Regional Pharma Trends report, PharmaBoardroom’s Patrick Burton explores some of the key recent…

Morocco   General Director Dr Aziz Mrabti discusses the Moroccan Medicines & Pharmacy Directorate (DMP)’s transition to an independent regulatory authority, highlighting its potential to enhance autonomy and international recognition. He also emphasizes Morocco’s commitment to supporting the growth of the healthcare and pharmaceutical sectors, both domestically and internationally, amid the…

Morocco Camilia Benani, recently promoted to partner at DLA Piper’s Casablanca office, explains why the Moroccan healthcare sector has become a lightning rod for M&A activity in recent years. Drawing on her experience advising many of the organisations involved in these deals, Benani touches on the evolution of deal structuring in…

Hong Kong Hong Kong provides some of the best and most efficient healthcare in Asia, with Hong Kongers living to over 85 on average (compared to 83 in Singapore and 78 in mainland China), and the World Health Organisation ranks the city among the top 20 healthcare systems globally. However, unlike many…

UAE Founded in July 2020, the Emirates Health Economics Society – led by Dr Sara Al Dallal – aims to create a space for the discussion of health economics within the UAE. In conversation with PharmaBoardroom, Dr Al Dallal outlines how the organisation’s collaborations with governmental, industry, and academic stakeholders are…

Europe The European Federation of Pharmaceutical Industries and Associations (EFPIA) has elected a new president and vice presidents who have set out a key priority for their term: a series of amendments to the proposed European Commission (EC) pharmaceutical legislation reform, which the organisation has warned will further accelerate the loss…