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
- 10 Firms Win Approval for Bilanoa Generics, 2 Contenders for Fycompa
February 17, 2026
- MHLW to Brand OTC-Like Drug Cost Rule as “Partially Non-Insured Care”
February 17, 2026
- Taiyo Pharma’s Propranolol Designated as Drug for Specific Use
February 17, 2026
- Japan Grants Orphan Tag to Bayer, Incyte Drugs, and 12 Others
February 17, 2026
- Japan to Delist 387 Drugs from NHI Price List, Including Renivace
February 16, 2026
Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…