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
- Pharma Group Looks to Growth Strategy under Takaichi after Election Win
February 10, 2026
- Pharma Groups Call for Faster Diagnosis and R&D for Intractable, Rare Diseases
February 9, 2026
- Generic Industry Consolidation Opens Opportunities for CMOs: Industry Chief
February 6, 2026
- FIRM Warns Conditional Approval Pricing Change Could Chill Regenerative Medicine R&D
February 3, 2026
- AMDD to Continue Policy Advocacy to Address Device Lag and Loss: Chair
January 28, 2026
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…





