Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
JPMA Official Renews Call for Use of “Specified Clinical Research” Data in Application Dossiers
A senior official of the Japan Pharmaceutical Manufacturers Association (JPMA) has reiterated the trade group’s push for the use of data from what is called “specified clinical research (tokutei rinsho kenkyu)” in early-stage trials and the conditional early approval system…
To read the full story
Related Article
- MHLW’s Panel Compiles Interim Paper for Promotion of Clinical Research, Trials
March 14, 2019
- HSC Panel Discusses Data Standardization to Promote Use of Real World Data
February 19, 2019
- “Detailed Discussions” Necessary for Use of Real World Data: HSC Panel
January 25, 2019
- JPMA Official Hails MHLW Discussions on Use of “Specified Clinical Research” Data in Application Dossiers
September 10, 2018
- MHLW Discussing Use of Data from “Specified Clinical Research” in Application Dossiers, Will Issue Preliminary Conclusions by March
August 29, 2018
- Tap Data from “Specified Clinical Research” for Early Trial, Conditional Approval: JPMA Official
April 24, 2018
- Use “Specified Clinical Research” Data for Drug Approval: Regulatory Science Society
March 23, 2017
REGULATORY
- AMED-Backed R&D Yielded 31 Regulatory Approvals in FY2025
July 17, 2026
- MHLW to Reconvene HSC Regulation Panel for First Time in a Year
July 17, 2026
- MHLW Allows Exceptional Concerta Pharmacy Transfers
July 17, 2026
- Japan to Consider Support for Domestic Immunoglobulin Production: Minister
July 16, 2026
- Govt Set to Amend Honebuto Draft over Inflation, MFN Language
July 16, 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…