REGULATORY
Late-Phase Trials with Overseas Participation Pragmatic Approach for Japan-Made COVID-19 Vaccine Development: PMDA Director
Yasuhiro Araki, director of the Pharmaceuticals and Medical Devices Agency’s (PMDA) Office of Vaccines and Blood Products, expressed his understanding that the PMDA will accept applications for approval of Japan-made COVID-19 vaccines based on overseas as well as domestic data,…
To read the full story
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





