Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Sets Up “Moderate-Risk” Post-Approval Change for Shorter Review
The Ministry of Health, Labor and Welfare (MHLW) has introduced a new category of post-approval procedures for “moderate-risk” manufacturing changes for ethical drugs, which would shorten the review period from the current median six months to 40 days. The new…
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
- MHLW Regulatory Panel OKs New Procedures for Post-Approval Manufacturing Changes
October 16, 2023
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
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…