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
Related Links
- Master File System
- GMP compliance inspection
- Regulations Regarding Living Modified Organisms (Genetically Modified Organisms)
- Japanese Pharmacopoeia(links to the website of the National Institute of Health Sciences)