CEP:
- CEP = Certificate of Suitability
- Issued by EDQM
- Confirm API complies with European Pharmacopoea
- Widely accepted across EU/ EEA
- Faster review process
ASMF:
- ASMF = Active Substance Master File
- Submitted to EU authorities via MAA
- API data splited into - open part and restricted part
- Used when CEP not available
- Longer review process
CEP is the preferred and more efficient route for EU API submissions whenever available, while ASMF serves as an alternative when CEP is not feasible.
Read also: CEP Filing Process | EDQM
