Japan will expand the eligibility criteria for the designation of “drugs for specific use” to include new active ingredients and introduce a framework allowing pharmaceutical companies to request designation themselves from May. The Ministry of Health, Labor and Welfare (MHLW)…
To read the full story
Related Article
- MHLW Issues 15 Notices Ahead of PMD Act Amendment
March 2, 2026
- MHLW to Add Company-Driven Route to “Specific-Use Drug” Designations
December 16, 2025
REGULATORY
- Japan Cabinet Approves National MCM Strategy to Boost Pandemic Response
March 25, 2026
- Pharma Urges Govt Support as Iran War Shows Early Impact on Supply Chains
March 25, 2026
- Japan Panel Slams MHLW’s 80% Single-IRB Target as Too Low
March 24, 2026
- Ishin Proposes Macroeconomic Indexing for Healthcare as LDP Talks Resume
March 24, 2026
- Japan OKs Bayer’s MRI Agent, Haihe’s PI3Kα Med, Enhertu’s Tumor-Agnostic Use, and More
March 24, 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…





