Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Looks to Rev Up Pediatric and Orphan Drug Initiatives in Next 5-Year Plan: Chief
The Pharmaceuticals and Medical Devices Agency’s (PMDA) new mid-term plan from this April aims to reduce the number of drugs particularly for pediatric and orphan diseases that are approved in major countries but not in Japan, Chief Executive Yasuhiro Fujiwara…
To read the full story
Related Article
- PMDA Sets 6-Month Target for All SaMD Products under Priority Review
January 23, 2024
- PMDA’s New Mid-Term Plan to Push Pediatric, Orphan Drug Development to Counter Losses
October 23, 2023
- MHLW to Book Budget to Launch Regulatory Advisory Center for Pediatric, Orphan Meds for FY2024
August 28, 2023
- MHLW to Seek 33.7 Trillion Yen Budget for FY2024
August 28, 2023
- MHLW Eyes Pediatric, Orphan Drug Advisory Team within PMDA: FY2024 Budget Request
August 25, 2023
REGULATORY
- Japan Sets Up Radiopharma Discovery Hub in Fukushima, Targets Rare Cancers
March 18, 2026
- MHLW Seeks Industry Survey on Petroleum-Linked Products amid Iran Crisis
March 18, 2026
- MHLW Orders Label Revisions for Antiepileptics and Other Drugs
March 18, 2026
- MHLW Panel OKs Draft Criteria for “Specified Medical Technologies”
March 17, 2026
- Growth Strategy Council WG Weighs Incentives for Clinical Trial Sites
March 17, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…