Tagged with regulatory,

Global Sarah Pope Miksinski, executive director/CMS regulatory affairs, and Gregory Rullo, senior director regulatory affairs, at AstraZeneca discuss the need for common ground among regulators and industry when it comes to patient centricity and for strategic leadership to address differing regulatory control-strategy requirements. In today’s increasingly complex and intricate pharmaceutical landscape,…

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2021. CDER approved 50 new drugs in 2021, down from 53 in 2020, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…

China The following is an overview from Accestra Consulting* of Part 2 of China’s Center for Drug Evaluation (CDE)’s 2020 reporting, including an overview of administrative drug approvals and fast track review pathways by CDE.   Abstract Despite severe challenges from the COVID-19 pandemic, the Center for Drug Evaluation (CDE) of…

China Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA), picks out the key learnings from recent legislation to improve China’s drug regulatory capacity and why it potentially marks a new era for the country’s innovative pharma industry.   On April 27, 2021, the General Office of…

Turkey Istanbul’s First Instance IP Court recently dismissed a negative declaratory action (the “Case”) against our client citing the plaintiff’s lack of standing because the pharmaceutical at issue was unlicensed as of the when the action was started. The ruling is noteworthy because it appears to confirm the precedential force of…

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…