Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
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
- Japan Nudged to Probe Wide Gaps in Biosimilar Uptake
November 6, 2026
- Japan Eyes Multi-Year Investment Support for Wholesalers in FY2027 Budget
November 6, 2026
- Japan Poised to Broker Generic Firms’ Product Consolidation Talks
November 6, 2026
- Japan Issues Guidance on AI Model Use in Drug Manufacturing, Quality Control
November 6, 2026
- JPMA Urges Foreign Price Rule Overhaul to Address US MFN Policy: LDP Hearing
November 5, 2026





