Certification of Suitability (CEP) – Overview
Filing Active Pharmaceutical Ingredient (API) information with the European Directorate for the Quality of Medicines & HealthCare (EDQM) is not mandatory; however, obtaining a Certification of Suitability (CEP) offers significant advantages for API manufacturers entering the EU market. CEPs can be filed only for APIs that have existing monographs in the European Pharmacopoeia (Ph. Eur.).
CEPs are widely recognized in emerging markets such as Australia, Canada, and EU countries, allowing API manufacturers to use a CEP instead of submitting an Active Substance Master File (ASMF) or Drug Master File (DMF). A Letter of Access (LoA) obtained from EDQM can be referenced in drug product applications, such as MAAs in EU countries, Therapeutic Goods Administration (TGA) submissions in Australia, and Abbreviated New Drug Submissions (ANDS) in Canada, streamlining the Regulatory process.
Given the specific EDQM requirements for CEP submission and approval, specialized expertise is essential to ensure quick approval of MAAs/ANDS. Freyr’s experienced Regulatory team provides end-to-end support in compiling, reviewing, and submitting CEPs in accordance with EDQM guidelines. With proven capabilities in handling CEP submissions for all types of APIs, including chemical, fermentation, and sterile APIs, X Pharma Plus is a trusted Regulatory partner for API manufacturers seeking efficient EU and global market access.
Certification of Suitability (CEP) – Services
“Confirms that the active substance meets European Pharmacopoeia standards, streamlining regulatory submissions and eliminating the need for a detailed ASMF in each application.”