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
- DMD Gene Therapy Elevidys Cleared for NHI Listing at 305 Million Yen
February 13, 2026
- MHLW Orders Label Revisions for Vyxeos, Inlyta, Imbruvica, and More Drugs
February 13, 2026
- MHLW Orders Label Revisions for Sulfite-Containing Medical Products
February 13, 2026
- PMDA Urges Proper Use of Colchicine, Advises against High-Dose Administration
February 12, 2026
- PMDA to Offer Priority Consultations for Overseas Startups
February 12, 2026
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…





