Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Kumamoto Quake Hits 46 Medical Facilities; No Pharma Damage Yet: MHLW
July 29, 2026
- Japan Shifts Mo-99 Supply Strategy toward Stronger Global Procurement: Panel
July 29, 2026
- 3 Label Expansions Get NHI Coverage on Public Knowledge Pathway
July 29, 2026
- No Cap on FY2027 Budget Requests under Growth Investment Scheme: MOF
July 29, 2026
- Japan Panel Green-Lights GSK’s Hep B Drug, Brinsupri, Hyrnuo
July 28, 2026
Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
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…