ORGANIZATION
Use “Specified Clinical Research” Data for Drug Approval: Regulatory Science Society
The Pharmaceutical and Medical Device Regulatory Science Society of Japan issued a proposal on March 22 calling for the use of data obtained from “specified clinical research (tokutei rinsho kenkyu),” defined in a bill currently under Diet deliberations, as part…
To read the full story
Related Article
- JPMA Official Renews Call for Use of “Specified Clinical Research” Data in Application Dossiers
December 7, 2018
- 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
- “Specified Clinical Research” Data with High Integrity Could Be Used for Drug Review: MHLW Councilor
May 8, 2017
- MHLW to Mull Use of Data from “Specified Clinical Research” for Drug Review: Official
April 10, 2017
ORGANIZATION
- Industry Hails Japan Growth Roadmap, PhRMA Urges Follow-Through
June 25, 2026
- Boehringer’s Hasson Appointed EFPIA Japan Vice Chair
June 22, 2026
- Think Tank Opposes Cap on Social Security Burden Ratio, Urges Pause in Off-Year Price Cuts
June 22, 2026
- Japanese Drug Makers Step Up Use of ASEAN Reliance Reviews
June 18, 2026
- Ease Foreign Price Adjustment Rules for New Drugs to Counter MFN Policy: FPMAJ
June 15, 2026
Recent trends are creating a fascinating push-and-pull effect in the talent market. We’re seeing more positions opening up, but also a greater number of candidates available, particularly in the fields of rare diseases and oncology. This “more positions, more candidates”…





