Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
A Japanese health ministry panel on October 31 gave the nod to a proposal to transfer authority to conduct GMP inspections for new generics from prefectural governments to the Pharmaceuticals and Medical Devices Agency (PMDA). The Health Sciences Council’s (HSC)…
To read the full story
Related Article
- Japan Sets Up “Moderate-Risk” Post-Approval Change for Shorter Review
October 1, 2024
- PMDA-Led Inspections Will Help Straighten Up Generic Makers: MHLW Councilor
September 6, 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
- Japan Panel to Review Brinsupri, Hyrnuo, Inlexzo, GSK’s Hep B Med on July 27
July 14, 2026
- CEA Review Group Debates Comparator Technologies, ICER Uncertainty
July 14, 2026
- MHLW Urges Stakeholders to Define Essential LLP Information
July 14, 2026
- Japan to Set Up Subgroup to Flesh Out Pharma Investment Roadmap: PM
July 13, 2026
- Immunization Act Revision Faces Uncertain Fate as Diet Clock Ticks Down
July 13, 2026
Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
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…