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 the European Pharmacopoeia (Ph. Eur).
Most of the emerging markets like Australia, Canada, and all the EU countries accept CEP instead of the Active Substance Master File (ASMF)/Drug Master File (DMF) submissions. Letter of Access (LoA) of CEP received from the EDQM can be provided to drug product applications like MAA to all the EU countries, Therapeutic Goods Administration (TGA) of Australia, and the Abbreviated New Drug Submission (ANDS) to Health Canada (HC) instead of the ASMF/DMF submission.
EDQM has specific requirements for the submission and granting of CEP for API/drug substances. Hence, expertise is required in filing CEPs with EDQM for quick approval of MAAs/ANDS.
Freyr has a strong Regulatory team with expertise in compilation, review, and submission of CEP to EDQM in line with the 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 the respective reports for submission.
- Gap-analysis of source documents/data generated for CEP submission in line with the current EDQM requirements/guidelines.
- Compilation, review, and submission of CEP in line with the EDQM requirements for APIs.
- Publishing of CEP in eCTD/NeeS/PDF as per the 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 the EDQM variation guidelines.
- Compilation, review, and submission of renewals for CEPs to maintain the lifecycle and validity of the granted CEP.
- Preparation of Regulatory strategy and response to Health Authority queries (RTQs) for quick approval of CEPs.