Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
It’s Time to Review Conditional Approval System for Regenerative Medicines: MHLW Official
The Ministry of Health, Labor and Welfare (MHLW) needs to review the way post-marketing evaluations are made for conditionally approved regenerative medicinal products, a senior ministry official said on March 25. Japan has so far approved four products under the…
To read the full story
Related Article
- FIRM Warns Conditional Approval Pricing Change Could Chill Regenerative Medicine R&D
February 3, 2026
- Japan Sets New Pricing Rules for Conditionally Approved Regenerative Medicines, Starting with Elevidys
January 15, 2026
- Chuikyo Backs Halving Profit Coefficient for Conditionally Approved Regenerative Medicines
November 13, 2025
- Chuikyo Urges Stricter Pricing Rules for Conditionally Approved Regenerative Medicines
October 16, 2025
- Chuikyo Agrees to Vet Conditional Scheme for Regenerative Medicine as Elevidys Gets Approval
May 15, 2025
REGULATORY
- PMDA Generic GMP Inspections a Real-World Test to Stem Startup Risks: Official
September 8, 2026
- CEA Review Finds Past Decisions Sound, Sees Room for More Transparency
September 8, 2026
- MHLW Adds Pomalyst Generics to RevMate Safety Program
September 8, 2026
- Japan Extends Shelf Life of Stockpiled Xofluza to 9 Years
September 8, 2026
- MHLW Seeks at Least 275 Billion Yen to Shore Up Drug Supplies
September 7, 2026
Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…