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
- Panel Clears Zolgensma Intrathecal Form to Expand Use in Older SMA Patients
March 10, 2026
- Japan Approves MSD’s HIV Combo Idvynso
March 9, 2026
- MHLW Updates Elective Care LLP List; Target Products Down Sharply to 776
March 9, 2026
- MHLW Orders Label Revisions for Cancer Drugs, Anticoagulant over Bleeding Risk
March 9, 2026
- Japan Health Minister Lauds Approval of iPSC-Based Therapies
March 9, 2026
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…





