REGULATORY
MHLW’s Planned Bill Would Exclude Certain Programs from “Specified Clinical Trials”
The Ministry of Health, Labor and Welfare (MHLW) will submit a bill to amend the Clinical Trials Act to an upcoming Diet session, which would remove certain types of programs from “specified clinical trials (tokutei rinsho kenkyu)” currently defined under…
To read the full story
Related Article
- MHLW to Present Detailed Criteria for Exclusion from “Specified Clinical Trials”
August 20, 2024
- Japan Enacts Bill to Amend Regenerative Medicine Safety Act, Clinical Trial Act
June 11, 2024
- Japan Cabinet OKs Bill to Amend Regenerative Medicine Safety Act, Clinical Trial Act
March 7, 2024
- LDP Panel OKs Bill to Amend Regenerative Medicine Safety Act, but Lawmakers Fret Lack of Ban on “Designer Babies”
February 22, 2024
- New Doctor Payment Disclosure Rule to Apply to Foreign Firms with Japan Subsidiaries
February 21, 2024
- MHLW Announces Revised Rule for Info Disclosure of Physician Payments
February 19, 2024
- Physician Meals Costs, Seminar Expenses Newly Subject to Disclosure under Clinical Trials Act from April
February 2, 2024
- Japan’s Diet Kicks Off 150-Day Regular Session, MHLW Plans 4 Bills
January 29, 2024
REGULATORY
- War-Linked Supply Concerns Rise to 43 Cases, Focus Shifts to Solvents, Packaging
April 24, 2026
- JPMA Pushes for “Freeze” on On-Patent Drug Price Cuts at LDP Meeting
April 23, 2026
- MHLW to Exclude High School-Age and Younger from OTC-Like Drug Charge: Official
April 23, 2026
- Japan, Singapore to Share GMP Inspection Results under Cooperation Pact
April 23, 2026
- MHLW Orders Label Revisions for Remicade, Enbrel, Bavencio, and More Drugs
April 22, 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…





