REGULATORY
MHLW to Mull Use of Data from “Specified Clinical Research” for Drug Review: Official
The Ministry of Health, Labor and Welfare (MHLW) will consider utilizing data from “specified clinical research (tokutei rinsho kenkyu),” defined under a recently enacted bill to regulate clinical research, as part of application dossiers for drug approval, a senior MHLW…
To read the full story
Related Article
- “Specified Clinical Research” Data with High Integrity Could Be Used for Drug Review: MHLW Councilor
May 8, 2017
- Certified IRBs to Review How Monitoring/Audits Will Be Conducted for “Specified Clinical Research”: Official
April 10, 2017
- Use “Specified Clinical Research” Data for Drug Approval: Regulatory Science Society
March 23, 2017
REGULATORY
- Officer Replacement Orders a “Last Resort” under PMD Act: MHLW Official
September 18, 2026
- Japan Panel Sees No Scientific Objection to Capvaxive NIP Addition
September 18, 2026
- Tavneos Blue Letter Action “Too Slow,” MHLW Panel Member Says
September 18, 2026
- Takaichi Tasks Ueno with Charting Growth Strategy for Drug Innovation
September 18, 2026
- Japan HIV, AIDS Cases Rise in H1 after 2025 Lows
September 18, 2026
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…





