The Ministry of Health, Labor and Welfare (MHLW) on February 27 simultaneously issued 15 notifications and administrative notices related to the upcoming amendment of the Pharmaceuticals and Medical Devices (PMD) Act. The documents primarily outline measures set to be enforced…
To read the full story
Related Article
- MHLW Clarifies Use of Real-World Data in Drug Applications
March 5, 2026
- MHLW Expands Eligibility for “Specific-Use Drug” Designation
March 5, 2026
- MHLW to Launch Priority Review Pathway for Overseas Alternatives amid Drug Shortages
March 5, 2026
- MHLW Revises Guidance on Pediatric Development Plans under Amended PMD Act
March 3, 2026
- MHLW Details New Operational Rules for Conditional Approvals from May
March 3, 2026
- MHLW Clarifies Up to 12-Year Data Protection for Pediatric Development
March 2, 2026
- MHLW Issues Guidance on Revised PMD Act Ahead of May Enforcement
January 6, 2026
- Japan’s Parliament Enacts Bill to Amend PMD Act
May 15, 2025
REGULATORY
- LDP, Ishin to Explore Role of Private Insurance in Reform Talks
April 14, 2026
- Japan Panel to Review Ferring Gene Therapy, Fujifilm Cell Product on April 20
April 14, 2026
- Middle East War Hitting API Air Freight, Trade Group Warns
April 13, 2026
- Japan’s 19th Pharmacopoeia Revision Takes Effect
April 13, 2026
- Voranigo and More Meds Missing from April Listing Slate; Servier Plans Packaging Change
April 10, 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…





