China China has made major healthcare strides over the past decade with regulatory reforms, infrastructure improvements, and the advancement of universal healthcare. While the COVID-19 pandemic revealed the need for further reform, the country continues to pursue the healthcare transformation goals established in its Health China 2030 program. These aspirations are…
Switzerland An extract from PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on price controls and reference pricing systems in Switzerland. Buy The Pharma Legal Handbook: Market Access & HTA – Switzerland here for £359. 1.1 How does price control at…
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.…
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…
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…
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…
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…
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…
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