Pediatric and Orphan Drugs

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

• Partial revision of “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults"[102KB]

March 29, 2024 PSB/PED Notification No. 0329-1

• Q&A for “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults”[140KB]

March 29, 2024 Administrative Notice

• Partial Revision of “Handling of Re-Examination Period”[94.7KB]

January 16, 2024 PSB/PED Notification No. 0116-3

• Planning of the Pediatric Drug Development Program during Development of Drugs for Adults[65.7KB]

January 12, 2024 PSB/PED Notification No. 0112-3

• Questions and Answers (Q&A) for Extension of Re-Examination Period in Association with Development of Pediatric Dosage and Administration[73.3KB]

November 26, 2020 Administrative Notice

• Handling of Designation of Drugs for Specific Use[105KB]

August 31, 2020 PSEHB/PED Notification No. 0831-5

• Re-Examination Period of Prescription Drugs[94.4KB]

August 31, 2020 PSEHB Notification No. 0831-11

• Considerations for the Clinical Evaluation of Drugs in Pediatric Patients (10 or 12 Years of Age and Older) Who Can be Evaluated Together with Adults[313.96KB]

June 30, 2020 PSEHB/PED Administrative Notice

Orphan Drugs

• Partial Revision of “Designation of Orphan Drugs etc.”[155KB]

January 16, 2024 PSB/PED Notification No. 0116-1・PSB/MDED Notification No. 0116-1

• Questions and Answers (Q&A) for Designation of Orphan Drugs etc.[104KB]

January 16, 2024 Administrative Notice