Filing Active Pharmaceutical Ingredient (API) Information with the European Directorate (ED) for the Quality of Medicines and HealthCare (EDQM) is not mandatory. However, possessing a Certification of Suitability (CEP) is an added advantage for API manufacturers while entering the EU. CEP to the monographs of the European Pharmacopoeia can be filed only for APIs which have monographs in European Pharmacopoeia (Ph. Eur).
Most of the emerging markets, in addition to Australia, Canada and all European Union (EU) countries accept CEP instead of Active Substance Master File (ASMF)/Drug Master File (DMF) submissions. Letter of Access (LoA) of CEP, received from EDQM can be provided to drug product applications like Marketing Authorization Application (MAA) to all EU countries, Therapeutic Goods Administration (TGA) of Australia & most of the emerging markets and Abbreviated New Drug Submission (ANDS) to Health Canada (HC) instead of ASMF/DMF submission.
EDQM has specific requirements for the submission and granting CEP for API/drug substances. Hence, expertise is required in filing CEPs with EDQM for quick approval of MAAs/ANDS.
Freyr has very strong Regulatory team with expertise in compilation, review and submission of CEP to EDQM in line with EDQM guidelines. With a strong footprint in handling CEP submissions to EDQM for all types of APIs (manufactured by chemical/Fermentation/ sterile), Freyr is proven to be a preferred Regulatory partner for API manufacturers.
- Identifying the Regulatory starting material and route of synthesis for APIs/drug substances
- Specification designing for starting materials, raw materials, excipients, packing materials, in-process, intermediates and drug substances
- Setting the strategy and limits for genotoxic and elemental impurities
- Finalization of stability protocol, process validation protocol, hold time study protocol, degradation study protocol and analytical method validation protocol and provide review support for respective reports for submission
- Gap analysis of source documents/data generated for CEP submission in line with current EDQM requirements/guidelines
- Compilation, review and submission of CEP in line with EDQM requirements for APIs
- Publishing of CEP in eCTD/NeeS/PDF as per EDQM guidelines
- Evaluation of change controls for post-approval changes (PAC)
- Regulatory assessment of PAC and preparation of variation submission strategy
- Compilation, review and submission of Variations (Type IA/Type IAIN/Type IB/Type II) to CEPs for PAC in line with EDQM variation guidelines
- Compilation, review and submission of Renewals for CEPs to maintain the lifecycle and validity of granted CEP
- Preparation of Regulatory strategy and response to health authority queries (RTQs) for quick approval of CEPs