Tagged with Regulator

Europe The much-discussed implementation of an EU-wide legislative framework on health technology assessment (HTA) will finally come to fruition in 2025, explains EUnetHTA Chair Niklas Hedberg. He outlines the need for this framework given the sheer influx of new products and the limited capabilities of individual countries and why the intervening…

Brazil The latest from Brazilian Pharma, including the controversial proposal to transform Brazil’s regulatory agency, ANVISA; Ease Labs’s canabidiol approval, Biolab’s international expansion ambitions and Eurofarma’s multiple myeloma deal.    ANVISA’s autonomy challenged by Congress (Regulatory Focus) After the swearing in Brazilian’s President Luiz Inácio Lula da Silva earlier this year,…

Japan Writing in the February 2023 edition of DIA’s Global Forum magazine, Yumi Wakabayashi of Janssen, Takahiro Horimatsu from the Institute for Advancement of Clinical and Translational Science at Kyoto University, Hiroshi Asai of Astellas, Yasuhiro Himeno from the Government of Japan’s Cabinet Office, and Hiroyuki Taruno of the Cancer Institute…

Denmark Denmark has long been a global frontrunner in medical research ethics and now boasts a more robust ethical infrastructure, spearheaded by a new body, The National Centre for Ethics. Head of the Centre’s Science and Ethics Division Helle Harder explains the rationale behind its formation, how ethics covers the quality…

USA An up-to-date list of the US FDA’s Center for Biologics Evaluation & Research (CBER)’s biological license application approvals for 2022. There were nine such approvals in 2022, down from 13 in 2021. For the list of non-biological approvals from the FDA’s Center for Drug Evaluation & Research (CDER), click here.…

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…