Tagged with Regulatory

USA Almost ten months into his presidency, Joe Biden has announced his pick to lead the US Food and Drug Administration (FDA). If confirmed by the Senate, the nominee, Dr Robert Califf, would become commissioner for a second time after leading the agency for almost a year at the end of…

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…

APAC Writing in the September edition of DIA’s Global Forum magazine, Rosilawati Ahmad of Malaysia’s National Pharmaceutical Regulatory Agency; Tharnkamol Chanprapaph of the Thai FDA; and Samvel Azatyan, Valerio Reggi, and Prapassorn Thanaphollert of the World Health Organization highlight the progress towards regulatory harmonization in ASEAN and work between country-level regulatory…

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…

China The following is an overview from Accestra Consulting* of Part 1 of China’s Center for Drug Evaluation (CDE)’s 2020 reporting, including data on drug approvals for all application types (including Investigational New Drugs (INDs), New Drug Applications (NDAs), and ANDAs), hot topics within new drug approvals for 2020, and reasons…

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 May edition of DIA’s Global Forum magazine, Toshiyoshi Tominaga of the Asia-Pacific Self-Medication Industry (APSMI) looks at the landscape for OTC medicines in the Asia-Pacific region today. Tominaga highlights how, against the backdrop of a drop in formal medical interventions due to COVID-19 infection fears, countries are more than…

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…

LatAm Writing in the April edition of DIA’s Global Forum magazine, Maria Cristina Mota Pina of Abbvie on behalf of FIFARMA Regulatory & Biologics Working Group highlights the significance of regulatory reliance between regulators in the LatAm and Caribbean region and proposes how it can be strengthened.   Regulatory reliance is…

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…

Europe Writing in the February edition of DIA’s Global Forum magazine, Thomas Kühler of Sanofi R&D looks at the future of European pharma post-Brexit, with the UK diverging from the rest of the continent in regulatory terms and the launch of the European Commission’s Pharmaceutical Strategy for Europe.   After four…

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…