REGULATORY
Japan Mulls Amendment of GCP Ordinance, Making Single IRBs a Rule
The Japanese health ministry is considering an amendment of its good clinical practice (GCP) ordinance with an eye towards incorporating the principle of a single institutional review board (IRB) per trial. The timeline for such changes is not yet determined.…
To read the full story
Related Article
- MHLW Pushes Back GCP Ordinance Revision to Summer
February 3, 2026
- New JPMA Task Force to Respond to ICH-GL and PMD Act Amendments
April 22, 2025
- Include Single IRB Policy in GCP to Accelerate Trials: EFPIA Official
February 10, 2025
- Consolidate IRBs to Streamline Clinical Trials in Japan: Govt Working Group
March 11, 2024
REGULATORY
- Avastin Price to Be Axed by 45% as G1 Rule Hits Originator Biologics
March 6, 2026
- Forxiga Slapped with 36% Price Cut on PMP Return in FY2026 Revision
March 6, 2026
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Japan's Revised Drug Distribution Guidelines Take Effect
March 6, 2026
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





