Regulatory Update
Understanding CEP vs. DMF: What Buyers Need to Know
A practical comparison of the two dossier pathways and what they mean for your import documentation.
When sourcing an Active Pharmaceutical Ingredient for a regulated market, buyers frequently encounter two different regulatory pathways used to support a supplier dossier: the Certificate of Suitability (CEP) and the Drug Master File (DMF).
Understanding which one applies to your target market — and what each actually guarantees — helps procurement and regulatory teams avoid delays late in the registration process.
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