Tagged with Regulator

Japan An overview of the new medicines approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) between April and November 2022. See the 2021 data here and the full PMDA approval archive here. Hecho conVisme Infographic Maker

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from 50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…

Portugal Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on post-market approval processes and regulations in Portugal. Buy The Pharma Legal Handbook: Market Access & HTA – Portugal here for £359.   What are the pricing principles and processes in your…

Africa Speaking exclusively to PharmaBoardroom, Medicines for Africa’s Lenias Hwenda gives a comprehensive overview of the African Medicines Agency, why such a regulatory body was needed, how it differs from the European Medicines Agency, and its progress thus far. Hwenda also examines how the AMA stands to impact Africa’s clinical trial…

China Accestra Consulting’s Zhao Lu* looks back on a year in which China’s Center for Disease Evaluation (CDE) rejected a record-breaking number of drug applications, explores some of the main reasons behind these rejections, and suggests how applicants can avoid them in future.   In 2021, China’s Center for Disease Evaluation…

Egypt First founded in 2019 as a new regulatory body independent from Egypt’s Ministry of Health, the Egyptian Drug Authority (EDA) has made significant progress over the last three years. Now recognised as one of the MEA region’s leading regulators, the EDA can point to several notable successes in Egypt’s battle…

Spain What major regulatory trends are emerging in Europe and in Spain? As one of the founding partners of a law firm focused uniquely on the life sciences industry, Faus & Moliner Abogados, Jordi Faus has been confronting the industry’s unique legal issues for over 25 years. In a recent PharmaBoardroom…

Spain Faus & Moliner Abogados is a Spanish law firm that has been specializing in pharma and life sciences law since 1997. Founding partner Jordi Faus explains how having a comprehensive knowledge of the industry has become the firm’s competitive edge. He discusses the push for regulatory innovation among European regulators,…

Vietnam Despite a decline in pharmaceutical sales during the COVID-19 pandemic, Vietnam is among the 17 countries with the most rapidly growing pharmaceutical industries in the world, as reported by nganhduoc.vn in its 2022 pharma industry forecast. With a market value of some USD 10 billion in 2020, according to another…

Canada Biosimilar uptake initiatives are gaining traction across Canada and have already been implemented in several provinces. Dara Jospé and Lina Bensaidane of Fasken examine the impact of these policies on patients, prescribers, and pharmacists thus far, and the implications should non-medical biosimilar switching become a nationwide norm.   In the…

Bahrain Dr Mariam Al Jalahma, CEO of the Kingdom of Bahrain’s National Health Regulatory Authority (NHRA) remarks on the healthcare transformation that led to the creation of the NHRA and explains the Bahraini regulatory body’s comprehensive responsibilities that range from the registration and pricing of essential medicines to the approval of…

Mexico Mexico’s pharma market, the second largest in Latin America and among the top 15 globally, is set to top USD 13 billion in sales by 2028. Despite the encouraging numbers, some industry insiders are bemoaning the current government’s healthcare missteps along with the country’s low public spending and regulatory hurdles.…