REGULATORY
MHLW Presents Policy for Use of “Specified Clinical Research” Data in Regulatory Submissions
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on March 31, providing its basic policy and points to note for the use of results obtained from “specified clinical research” in regulatory submissions. Specified clinical research (tokutei rinsho…
To read the full story
Related Article
- MHLW to Make Case-by-Case Decisions on Use of “Specified Clinical Research” Data in Regulatory Filings
April 6, 2023
- MHLW Official Sees More “Specified Clinical Research” Data Used in Regulatory Submissions to Fill Industry-Academia Void
July 20, 2022
- NCC Doctor Hails MHLW’s Policy on Use of Clinical Research Data in Regulatory Filing
June 22, 2022
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…





