The government’s Regulatory Reform Promotion Council presented a recommendation to Prime Minister Yoshihide Suga on June 1, urging the government to facilitate management of clinical trials and promote the development of software as a medical device (SaMD). After receiving an…
To read the full story
Related Article
- Regulatory Reform Panel Urges Better Trial Environment, SaMD Review
December 24, 2021
- Industry Calls for Simplifying Regulatory Process for SaMD
October 26, 2021
REGULATORY
- 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
- MHLW Panel Calls for Careful Design of OTC-Like Drug Charge System
March 23, 2026
- Japan Hands Out Orphan Tags to Ianalumab, Bleximenib, and Lots More Drugs
March 23, 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…





