Tagged with PMDA

Japan Writing in the September 2025 edition of DIA’s Global Forum magazine, Seiko Usami, Shinichi Noda, Daisuke Koga, and Naoyuki Yasuda of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan’s regulatory body, outline the benefits for global pharma of including Japan in their drug development activities.   Japan is one of…

Global In an era of rapid scientific breakthroughs, global regulators are navigating new challenges—accelerating approvals, harmonising standards, and integrating digital tools—while balancing safety, efficacy, and access. Throughout 2024, PharmaBoardroom spoke with regulators worldwide to uncover the key regulatory trends shaping the future of healthcare in 2025 and beyond.   The Road…

Japan In conversation at DIA Europe 2024 in Brussels, Shinobu Uzu of Japan’s regulatory agency, PMDA, laid out the organisation’s new five-year plan, how PMDA is hoping to incentivise more biopharmaceutical R&D in the country, and why Japan is “the gateway to Asia” in regulatory terms.   International pharmaceutical companies [should]…

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

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

Japan Writing in the October edition of DIA’s Global Forum magazine, Chief Executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Yasuhiro Fujiwara outlines how his agency has begun to utilise real-world data (RWD) and real-world evidence (RWE) in its regulatory decision-making processes and how this will evolve moving forward.  …

Japan Following on from our recent compilations of 2020 new drug approvals in the USA, China, and Switzerland, see below for the Japanese PMDA’s new drug approvals list for April-October 2020. Made with Visme Infographic Maker  

Japan A comprehensive list of the new drugs approved by Japan’s Pharmaceutical and Medical Devices Agency (PMDA) in 2019. Made with Visme Infographic Maker  

Japan In April 2019, Yasuhiro Fujiwara was appointed as the new chief executive of Japan’s drug regulator and one of the world’s foremost regulatory bodies, the Pharmaceuticals and Medical Devices Agency (PMDA). Upon appointment, Fujiwara coined the “Four Fs” strategy, urging PMDA employees to have a “patient first,” “access first,” “safety…

Japan Dr. Tatsuya Kondo is chief executive of Japan’s regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA). Since taking the role in 2008, Dr. Kondo, a qualified neurosurgeon with wide-ranging experience in R&D activities, has been responsible for all the operations of PMDA, including relief for adverse health effects of…