Tagged with Regulator

Egypt The head of the Pharmaceutical Chamber of the Federation of Egyptian Industries, Gamal El-Leithy, shares his view on the positive developments driving the growth of Egypt’s pharma market, including the creation of an independent regulatory body and a procurement agency. In addition, he analyses the country’s response to the COVID-19…

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,…

Italy Domenico Mantoan, General Manager of AGENAS, the Italian National Agency for Regional Health Services, discusses the role of the agency in Italy’s decentralised healthcare system, the National Recovery and Resilience Plan’s aim to improve territorial inequalities, and the National Outcomes Program managed by AGENAS on behalf of the Ministry of…

Americas Collaboration, convergence, and other best practices have been at the center of discussions related to the regulatory environment in Latin America and the Caribbean, including DIA’s Latin America Regulatory Conference (LARC) 2022, where voices from global regulators, regional and international organizations, industry, and academia discussed the strategies supporting current practices and…

Asia-Pacific Writing in the June edition of DIA’s Global Forum magazine, Ellen Sem, Fengyun (Vicky) Han and Annetta C. Beauregard from Janssen Pharmaceutical Companies of Johnson & Johnson, outline the real-world data (RWD) and real-world evidence (RWE) regulatory landscape in Asia Pacific.  Real-world data (RWD) and real-world evidence (RWE) have played an…

Italy Giorgio Palú, President of the Italian Medicines Agency (AIFA) helps us understand how the agency works, explains the criteria they use to evaluate innovative medicines and tells us about AIFA’s independent research program. AIFA has always favoured innovation and, in this context, has defined specific criteria with the aim of…

Europe Nick Sykes of Pfizer discusses the European Commission’s intention to “future-proof” the EU regulatory system and the suggestions for changes that were discussed througout the DIA Europe 2022 meeting. From the May edition of DIA’s Global Forum magazine. In its Pharmaceutical Strategy, the European Commission intends to “future-proof” the EU…

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…