Tagged with regulatory,

Asia-Pacific Writing in the April edition of DIA’s Global Forum magazine, Dhiraj Behl, Janine Jamieson, and Harikesh Kalonia highlight some of the regulatory challenges for drug-device combination products in APAC, including the lack of an international body dedicated to harmonisation in this field.   In the current innovation era and in the wake…

Singapore Dr Choong May Ling, Mimi, CEO of Singapore’s Health Sciences Authority (HSA), one of the leading regulatory bodies in the Asia-Pacific region, outlines the impact of Singapore’s status as a life sciences hub, the launch of novel priority review avenues, and how the authority is adjusting to the new industry…

China Writing in the February edition of DIA’s Global Forum magazine, Xu Wang of Novo Nordisk Pharma China and Xiaoxi Wang from the Shanghai Center for Drug Evaluation & Inspection analyse the Chinese NMPA’s drug approval list for 2020, including a surge in approvals for locally developed drugs.   In the…

USA In 2020, the US FDA’s Center for Drug Evaluation & Research (CDER) approved 53 novel drugs, up from 48 in 2019, across a range of therapeutic areas, including the first treatments for COVID-19 patients.   The FDA’s Center for Biologics Evaluation & Research (CBER) is charged with approving new biologic…

Europe The European Medicines Agency (EMA), Europe’s regulatory body for medicines, has nominated Irish candidate Emer Cooke to as its new executive director at a crucial time for the agency as its powers and priorities shift in the wake of the COVID-19 crisis.   If Cooke accepts and gives an official…

Czech Republic Martin Mátl, executive director of the Czech Association of Pharmaceutical Companies (ČAFF), shares the key priorities and challenges of the association and its members; assesses the Czech generics ecosystem, and gives insight into the importance of generics in providing a sustainable healthcare environment with ready availability of medicines for patients.…

Regulatory This week Novartis received approval from the European Commission (EC) for Kymriah, their chimeric antigen receptor T cell (CAR-T) therapy for young people under 25 with cancer of the blood. Leading the way in innovative cancer cures with an unrivalled portfolio of over 20 approved oncology medicines, Novartis is the only company in the…

Pharma Providing universal health coverage to the nation’s roughly 10 million citizens, Hungary’s National Health Insurance Fund (OEP) has one of the most comprehensive and complex structures in Europe. The organization’s Head of Pricing Support, Dr. Judit Bidló discusses the current mechanisms governing pharmaceutical reimbursements in Hungary, while also identifying the…

pharma With almost thirty years of experience in the life sciences sector, local Dutch consultancy firm Baggerman Farma Consult offers a wide portfolio of services to its clients in the pharmaceutical and life sciences industry to meet all of their regulatory needs. Kees Baggerman, CEO and founder, highlights the new Gateway…

AstraZeneca Rodrigo Fernandez became country president of AstraZeneca Central America, Caribbean, and Middle Andean Countries (CAMCARMAC) in July 2013. He discusses the challenges across the region for regulation and distribution channels, with an emphasis on the complexities of the Peruvian market. What were your initial priorities when you became head of…

regulatory Santiago Garcia Belmonte, president of Biosidus, discusses how global regulatory trends are driving change in the Argentinian biotech industry, as well the new direction his firm has taken over the last five years. How would you describe the recent changes in the biotech market and the industries new direction? Things…

Almirall Having only arrived on the market last year, the GM of Almirall in Canada explains the company’s regulatory struggles, the utilization of Almirall’s global R&D infrastructure in Canada as well as the company’s choice to enter the Canadian market and what products they are introducing into it.   You started…