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’s 1st Xolair Biosimilar Likely from Celltrion as JAN Is Assigned
January 23, 2026
- DPP Vows to Scrap Off-Year Drug Price Revisions in Election Platform
January 23, 2026
- Japan Starts Review on Scope of Drugs Eligible for Immunization Use, with Beyfortus in Focus
January 23, 2026
- Takeda’s Miyabashira Urges National Strategy Act to Revive Japan as Innovation Powerhouse
January 22, 2026
- LDP Pledges to Position Pharma as Core Industry in Campaign Platform
January 22, 2026
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…





