REGULATORY
PAFSC 1st Committee to Discuss Japan’s First PCSK9 Inhibitor on Nov. 27
The Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) First Committee on Drugs, an advisory organ to the health minister, will review whether to recommend approval of what would be Japan’s first PCSK9 inhibitor on November 27. Evolocumab, filed by Amgen…
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…





