The Central Social Insurance Medical Council, a key Japanese reimbursement policy panel better known as Chuikyo, approved an outline of…
REGULATORY
MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
A key Japanese health ministry panel launched discussions on an amendment of the Pharmaceuticals and Medical Devices (PMD) Act on February 9. According to a timeline presented, it will start debates on individual topics in April-May and hold one or…
To read the full story
Related Article
- Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
November 5, 2024
- Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
October 4, 2024
- Make Onsite GMP Inspections Mandatory for Patented Meds and New Generics: MHLW Proposal
June 10, 2024
- MHLW Proposes Creating Legal Provision on RWD-Only Drug Submissions
June 10, 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
- Legal Changes on Horizon for GMP Inspection Authorities, Other Regulation Panel Topics?
February 7, 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
- MHLW Pharma Director Says Uniform Drug Price Hike “Not Realistic,” Targeted Support Preferred
January 9, 2026
- MHLW Issues Guidance on Revised PMD Act Ahead of May Enforcement
January 6, 2026
- MHLW Sets Up Drug Discovery Support Office Ahead of New Fund Launch
January 6, 2026
- Ex-JPMA President Ueno Takes on New AMED Advisor Role
January 6, 2026
- Cabinet OKs FY2026 Tax Reform Package, Creates Strategic Tech R&D Credit
January 5, 2026
As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…
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…
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…