CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia)
- Issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM).
- Confirms that an Active Pharmaceutical Ingredient (API) complies with the European Pharmacopoeia (Ph. Eur.) monograph.
- Simplifies regulatory approval in European countries.
DMF (Drug Master File)
- A confidential document submitted to regulatory agencies (like the FDA in the U.S.) that provides detailed information about an API’s manufacturing, stability, and quality.
- Helps drug manufacturers get approval without disclosing proprietary data to customers.
CADIFA (Certificado de Adequação de Insumo Farmacêutico Ativo)
- Brazil’s equivalent of CEP, issued by ANVISA (Agência Nacional de Vigilância Sanitária).
- Ensures the quality and compliance of an API for use in pharmaceuticals in Brazil.
ASMF (Active Substance Master File)
- Similar to a DMF but used in the European Union (EU), UK, and other regions.
- Submitted to regulatory agencies to protect confidential API manufacturing details while allowing reference in drug applications.
Each of these regulatory documents serves a similar purpose: ensuring the safety, quality, and compliance of APIs in different global markets. Let me know if you need more details on any of these!
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