Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW to Make Case-by-Case Decisions on Use of “Specified Clinical Research” Data in Regulatory Filings
The Ministry of Health, Labor and Welfare (MHLW) will make decisions on whether to allow the use of data from “specified clinical research” on a case-by-case basis, but only under certain conditions, such as when registrational trials are deemed infeasible,…
To read the full story
Related Article
- MHLW Official Sees More “Specified Clinical Research” Data Used in Regulatory Submissions to Fill Industry-Academia Void
July 20, 2022
- NCC Doctor Hails MHLW’s Policy on Use of Clinical Research Data in Regulatory Filing
June 22, 2022
- MHLW Presents Policy for Use of “Specified Clinical Research” Data in Regulatory Submissions
April 4, 2022
REGULATORY
- 874 Defects or Health Damages Reported for Regenerative Medical Products in 1H FY2025
March 13, 2026
- Chuikyo OKs Listing of J&J’s Rybrofaz, Peak Sales Seen at 43.8 Billion Yen
March 12, 2026
- GSK’s Exdensur, Lilly’s Inluriyo Missing from March Listing Roster
March 12, 2026
- Truqap Price Cut Set at 10.7% from June under CEA Scheme
March 12, 2026
- Avelox Gains Coverage for MDR-TB via Public Knowledge Filing
March 12, 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…