Japan’s New Emergency Regulatory Approval System
Pfizer’s Kaneko Miyuki, writing in the September 2022 edition of DIA’s Global Forum magazine, shines a light on Japan’s new emergency approval system for pharmaceuticals. Enacted in the wake of…
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…
Pfizer’s Kaneko Miyuki, writing in the September 2022 edition of DIA’s Global Forum magazine, shines a light on Japan’s new emergency approval system for pharmaceuticals. Enacted in the wake of…
The latest healthcare and pharma news from Japan, including Shionogi’s COVID-19 pill, the Japanese parliament’s green light for emergency approvals of drugs and vaccines and Hitachi’s partnership with Invivoscribe. …
In the five years since the Japanese drugmaker began a strategic shift and created an ambitious plan to maintain growth, CEO Kenji Yasukawa helped Astellas move away from its previous…
Dr Ken-ichiro Hata, representative director and chairperson of Japan’s Forum for Innovative Regenerative Medicine (FIRM) outlines the organisation’s mandate, how Japan has been able to cultivate one of the world’s…
Experienced global leader Takafumi Horii explains the rationale behind returning to his home nation of Japan to head up Takeda’s Japan Oncology operations. Horii also touches on the significant burden…
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…
MSD KK’s Fumitaka Noji, writing in the January 2023 edition of DIA’s Global Forum magazine, outlines some of the key upgrades that Japan’s innovation ecosystem needs to become globally competitive…
Some of the biggest stories coming out of Japanese pharma, including Takeda’s USD 2.2 billion Alzheimer’s deal with AC Immune and its plans to restructure; the continuing probe into deaths…
Writing in DIA’s Global Forum magazine for June 2024, Mamoru Narukawa of Kitasato University Graduate School of Pharmaceutical Sciences takes a look at some of the positive trends impacting Japan’s…
Real-world data (RWD) offers the possibility of providing important information to help inform regulatory decision-making. But turning this possibility into reality still depends on the quality and reliability of the…
Toshi Tominaga of Keio University Hospital, writing in the January 2023 edition of the DIA Global Forum magazine, outlines some recent updates to Japanese drug registration legislation, including how domestically…
Writing in DIA’s Global Forum magazine for April 2024 on behalf of DIA Japan’s Open Innovation Community Fumitaka Noji, Takeshi Kono, and Makoto Nagaoka look at how the gap between…
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