REGULATORY
PMDA to Set Up New Consultation Services for RWD Use in Regulatory Submissions
The Pharmaceuticals and Medical Devices Agency (PMDA) will start offering new consultation services next month for the use of registry data in new drug applications (NDAs) and reexamination applications for drugs and regenerative medicine products. The move comes as part…
To read the full story
Related Article
- RWD Use in Regulatory Submissions Could Start with Rare Diseases: PMDA Chief
September 10, 2019
REGULATORY
- Nakai Tapped as MHLW’s Top Pharmacy Officer; Ohara to Steer Drug Pricing Reform
August 7, 2026
- Sarclisa SC, Joenja, Kineret, and 7 More Drugs Bound for NHI Listing
August 6, 2026
- Tepezza Price Cut Set at 5.5% under Japan’s CEA Scheme
August 6, 2026
- Dupixent Faces Fourth Re-Pricing under Japan’s SPA-SSS
August 6, 2026
- Chuikyo Clears NHI Listing for Oncolys’ Telomelysin
August 6, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…





