Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
A Japanese health ministry panel on October 3 endorsed a list of seven proposals related to regulatory reviews towards the next amendment of the Pharmaceuticals and Medical Devices (PMD) Act. At the centerpiece of the plans are measures to facilitate…
To read the full story
Related Article
- Japan Sets Up “Moderate-Risk” Post-Approval Change for Shorter Review
October 1, 2024
- Japan Eyes Withdrawal Rule for Conditional Approval, More Flexible Nods
June 10, 2024
- JPA Wary of FPMAJ Pitch to Allow Non-Pharmacists as Drug Production Managers
May 21, 2024
- Allow Use of OOS Autologous Cell Products via PMD Act Amendment: FIRM
May 21, 2024
- Pharma Industry Wants “Internationally Harmonized” Rules under PMD Act
May 20, 2024
- MHLW Panel Sets Topics for PMD Act Amendment; Pediatrics, Drug Loss on Agenda
April 19, 2024
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
REGULATORY
- LDP Panel Finalizes Honebuto Proposal on Preventive Care, Adds Obesity Focus
June 5, 2026
- Ex-GSK Japan Head Calls for End to "Obsolete" 14-Day Prescription Limit
June 5, 2026
- Trazenta Generic Outlook Remains Clouded as Court Upholds Treatment-Method Patents
June 4, 2026
- LDP Generic Caucus Wants Swift Disclosure of Company Indicator Ratings
June 4, 2026
- LDP Social Security Panel Pushes Greater Reward for Innovation: Honebuto Proposal
June 3, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…