Tagged with M

Pharma Legal Handbook  1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health and Care Services (Helse- og Omsorgsdepartementet, “HOD”) is the superior administrative authority in Norway, with jurisdiction over drugs, biologicals, and medical devices.   The Norwegian Medical Products Agency (Direktoratet…

Pharma Legal Handbook  53. What types of liability are recognized in your jurisdiction? Liability under Norwegian law can be distinguished between civil and criminal liability. Criminal liability may be incurred by anyone who violates penal provisions, either in the penal code, or provisions in other acts of legislation which is sanctioned with criminal…

Pharma Legal Handbook 58. What are the basic requirements to obtain patent and trademark protection?   Patents: The most basic requirements follow from the Norwegian Act relating to patents of 15 December 1967 No. 9 (“the Patents Act”). The Patents Act § 2 stipulate that patent protection may be granted to anyone who…

Middle East & Africa A lot has happened at Olympus since we last spoke with regional managing director for Middle East, Türkiye & Africa Ronald Boueri two years ago. Namely, the MedTech has been working on setting up its regional headquarters in Saudi Arabia. Boueri discusses the importance of the Saudi market, pursuing its…

USA Since founding the HIV advocacy group Prevention Access Campaign (PAC) and launching its Undetectable=Untransmittable (U=U) campaign in 2016, Bruce Richman has been focused on raising awareness around a revolutionary but widely unknown fact: people living with HIV who are on treatment and have an undetectable viral load cannot sexually transmit…

China Cytiva is a global leader in bioprocessing technologies and services that support the manufacturing and research of biopharmaceuticals. China is a key market in the company’s growth story, where – as President of Cytiva in China Allen Li notes – it has shifted from simply offering superior products to engaging…

China Unlike many of its Chinese biotech peers with broad portfolios, Hua Medicine has focused intensively on developing a single product, dorzagliatin, for diabetes. As CEO Li Chen notes, this strategic concentration has allowed Hua Medicine to pioneer in homeostasis control modulation and address specific unmet medical needs in diabetes treatment,…

India Environmental, Social, and Governance (ESG) concerns have grown in global importance in the last few years due to several factors, including increased awareness of and demand for sustainable investing, the need for companies to maintain what McKinsey calls their ‘social license’, and the potential financial benefits of strong ESG performance.…

China Yoshitaka Koketsu explains Sumitomo Pharma Group’s positioning in the China market as a relatively recent market entrant with a six-product portfolio but with plentiful opportunities for further growth, particularly in combating infectious diseases and antimicrobial resistance (AMR). Koketsu outlines how the company is well-aligned with China’s regulatory changes, and how…

LatAm For the second consecutive year, DIA Europe hosted a Latin America Town Hall, a panel discussion to foster collaboration and share updates from regulatory activities in Latin America and Europe, and the intersections between them. MSD’s Leonardo Semprun, writing in the May 2024 edition of DIA’s Global Forum magazine, highlights…

Mexico In a move to address medicine shortages Mexico’s outgoing president Andrés Manuel López Obrador last year launched a Super Pharmacy, or “Megafarmacia del Bienestar,” dubbed the largest medicine stockpile n the world. But with the country’s presidential elections looming and evidence that few prescriptions have actually been filled, detractors say…

UK Throughout his long career, John-Arne Rottingen has gathered experience across multiple domains from discovery research to public health and diplomacy that led him to become the founding CEO of the Coalition for Epidemic Preparedness Innovation (CEPI). In January he took on the leadership of the UK-based foundation Wellcome, coinciding with…