Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Legal Changes on Horizon for GMP Inspection Authorities, Other Regulation Panel Topics?
The Ministry of Health, Labor and Welfare (MHLW) appears to be looking at potential legal amendments to address issues related to pharmaceutical regulations, including the review of authorities to conduct GMP inspections and post-approval procedures for manufacturing changes. On February…
To read the full story
Related Article
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
- MHLW to Kick Off Debates on PMD Act Amendment on Feb. 9
February 5, 2024
- MHLW Plans Joint Surprise Onsite Inspections by PMDA and Prefectural Govts
November 16, 2023
- MHLW Regulatory Panel OKs New Procedures for Post-Approval Manufacturing Changes
October 16, 2023
REGULATORY
- 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
- Extra Charges Likely for OTC-Like Drugs to Treat Seasonal Conditions: Minister
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…
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…