The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
MHLW Starts Seeking Drug Development Requests under New Scheme
The Ministry of Health, Labor and Welfare (MHLW) has begun inviting requests from medical societies and patient groups to develop unapproved drugs and indications under a new development request scheme, which covers medicines not approved in any country. The MHLW…
To read the full story
Related Article
- Council OKs Applications Based on Data from Public Domain for 3 Drugs Including Lidocaine
July 14, 2015
- Panel on Unapproved Drugs Weighs Revamp upon Rollout of New Development Request Scheme
January 27, 2015
- MHLW Panel OKs Tweaked Requirements for New Development Request Scheme
October 15, 2014
- MHLW Panel to Elaborate Proposed Scheme to Broaden Drug Development Requests
July 15, 2014
REGULATORY
- Japan Approves Batch of New Drugs, Subcutaneous Rybrevant Finally Cleared
December 23, 2025
- Japan, Spain Move to Deepen Pharmaceutical Regulatory Cooperation
December 23, 2025
- Japan Drops Transitional Plan for PCV20 Routine Shot in Elderly
December 23, 2025
- Tecartus Now in Line for Orphan Status with Japan Panel Nod
December 23, 2025
- LDP, Ishin Strike Deal on OTC-Like Drugs, Patients to Pay “1/4” Special Charge
December 22, 2025
Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…