REGULATORY
PMDA Looks to Rev Up Pediatric and Orphan Drug Initiatives in Next 5-Year Plan: Chief
The Pharmaceuticals and Medical Devices Agency’s (PMDA) new mid-term plan from this April aims to reduce the number of drugs particularly for pediatric and orphan diseases that are approved in major countries but not in Japan, Chief Executive Yasuhiro Fujiwara…
To read the full story
Related Article
- PMDA Sets 6-Month Target for All SaMD Products under Priority Review
January 23, 2024
- PMDA’s New Mid-Term Plan to Push Pediatric, Orphan Drug Development to Counter Losses
October 23, 2023
- MHLW to Book Budget to Launch Regulatory Advisory Center for Pediatric, Orphan Meds for FY2024
August 28, 2023
- MHLW to Seek 33.7 Trillion Yen Budget for FY2024
August 28, 2023
- MHLW Eyes Pediatric, Orphan Drug Advisory Team within PMDA: FY2024 Budget Request
August 25, 2023
REGULATORY
- Briviact Set for Price Cut with CEA Adjustment Rate of 0.1
April 9, 2026
- Chuikyo Sets Reimbursement Pathways for Five Regenerative Medicine Products
April 9, 2026
- Japan OKs Listing of Exdensur, Aquipta, Tukysa, and More; New Price Rules Applied to Two
April 9, 2026
- Chuikyo Names Hosei Prof. Sugahara to Drug Pricing, CEA Panels
April 9, 2026
- MHLW Publishes Updated LLP List with Higher Surcharges from June
April 8, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





