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Reviews and Related Services

Pediatric and Orphan Drugs

Links to major regulatory information of pediatric and orphan drugs.

Regulations and Notifications

Pediatric Drugs

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

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