Tagged with Regulator

LatAm Writing in the March edition of DIA’s Global Forum magazine, the University of Southern California’s Viktoria Magyar looks at how Latin American regulatory bodies adapted to the COVID-19 pandemic and what some of its longer-term impacts on regulatory activities in the region might be.   Driven by increasing workloads, limited…

Japan An overview of the new medicines approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) between April and November 2021. See the 2020 data here and the full PMDA approval archive here. Made with Visme Infographic Maker

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…

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…

Global Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for COVID-19 vaccines have evidently been top of their priority lists, other key topics discussed included the potential of data and AI to change the drug approval…

Denmark In a wide-ranging interview, incoming director general of the Danish Medicines Agency Lars Bo Nielsen discusses the challenges that personalised medicine presents to regulators, building a stronger international presence for the Agency, and better leveraging the country’s world-class data infrastructure while respecting the EU’s data protection regulation.   Within Europe,…

Turkey TITCK is the regulatory agency in charge of ensuring the safety of medicines, health products, cosmetics, and personal care products in Turkey. Its recently appointed president, Dr Tolga Karakan, discusses the agency’s work with the WHO, ICH and EU Commission to help Turkish patients and consumers, their experience with emergency…

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…