Links to major regulatory information of pediatric and orphan drugs.
Regulations and Notifications
Pediatric Drugs
- Initiatives to Promote Pediatric Drug Development [229KB]
March 21, 2025 PMDA/CPE Notification No. 1618・PMDA/CRS Notification No. 15
March 29, 2024 PSB/PED Notification No. 0329-1
March 29, 2024 Administrative Notice
January 16, 2024 PSB/PED Notification No. 0116-3
January 12, 2024 PSB/PED Notification No. 0112-3
November 26, 2020 Administrative Notice
August 31, 2020 PSEHB/PED Notification No. 0831-5
August 31, 2020 PSEHB Notification No. 0831-11
June 30, 2020 PSEHB/PED Administrative Notice
Orphan Drugs
January 16, 2024 PSB/PED Notification No. 0116-1・PSB/MDED Notification No. 0116-1
January 16, 2024 Administrative Notice