Pediatric and Orphan Drugs

Links to major regulatory information of pediatric and orphan drugs.

Regulations and Notifications

Pediatric Drugs

• Partial Revision of "Re-Examination Period of Prescription Drugs"[33.7KB]

February 27, 2026 PSB Notification No. 0227-1

 

• Partial Revision of "Handling of Re-Examination Period"[114KB]

February 27, 2026 PSB/PED Notification No. 0227-2

 

• Questions and Answers (Q & A) for Handling of Re-examination Period[41.6KB]

February 27, 2026 Administrative Notice

 

• Partial revision of "Planning of the Pediatric Drug Development Program during Development of Drugs for Adults"[22.8KB]

February 27, 2026 PSB/PED Notification No. 0227-8

 

• Revision of Q & A for "Planning of the Pediatric Drug Development Program during Development of Drugs for Adults"[64.2KB]

February 27, 2026 Administrative Notice

 

• Partial Revision of "Handling of Designation of Drugs for Specific Use"[249KB]

February 27, 2026 PSB/PED Notification No. 0227-9

 

• Utilization of Sample Informed Consent Form and Assent Form in Pediatric Clinical Trials (Request)[82.7KB]

November 27, 2025 HPB/RDD Notification No. 1127-1・PED/PSB Notification No. 1127-3

 

• Initiatives to Promote Pediatric Drug Development [229KB]

March 21, 2025 PMDA/CPE Notification No. 1618・PMDA/CRS Notification No. 15

 

• 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

 

• 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