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Reviews and Related Services

Quality

Links to major regulatory information of Quality.
 

​Regulations and Notifications

GMP

March 30, 2005 PFSB/ELD Notification No. 0330006・PFSB/CND Notification No. 0330005

Clinical Trial Notification

January 16, 2025 Administrative Notice

Oligonucleotide Therapeutics

June 9, 2022 PSEHB/PED Administrative Notice

 

September 27, 2018 PSEHB/PED Notification No. 0927-3

Application for Marketing Approval

January 16, 2025 Administrative Notice

 

February 10, 2005 PFSB/ELD Notification No. 0210001

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