Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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
- Japan OKs Coverage for Susmed Insomnia App, Shionogi ADHD Therapy App
May 15, 2026
- MHLW’s Mori Vows to Make Japan Pharma Market “More Attractive”
May 15, 2026
- MHLW Official Says US MFN Policy Could Be Taken Up by Chuikyo
May 15, 2026
- Oncolys’ Telomelysin Up for Japan Panel Review on May 21
May 15, 2026
- Japan to Launch CEA “Technical Discussions” under MHLW Research Group
May 14, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…