REGULATORY
PMDA Raises Caution on Teratogenicity of Keratosis Treatment Tigason, Urges Use Only in Serious Cases
The Pharmaceuticals and Medical Devices Agency (PMDA) raised caution regarding the risk of teratogenicity due to Chugai Pharmaceutical’s keratosis treatment Tigason (etretinate) on March 3, after the second case of congenital abnormality was reported in Japan following the administration of…
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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
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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…





