Filing Active Pharmaceutical Ingredient (API) information with the European Union (EU) Health Authorities (HAs) is not mandatory. However, to maintain confidentiality and to refer for multiple Marketing Authorization Applications (MAAs), API manufacturers, as a practice file the information in Common Technical Document (CTD) format either as Active Substance Master Files (ASMFs) through any of the EU filing procedures (CP/NP/DCP/MRP) or as a Certification of Suitability (CEP) with the European Directorate for the Quality of Medicines and HealthCare (EDQM).
Once API information is filed with the HA and the same is accepted, the ASMF can be referred through a Letter of Access (LoA) to multiple MAAs in order to avoid duplication. Regulatory submission requirements for API/drug Substance in EU are very specific and different from other countries. Hence, expertise and experience in ASMF filing is required for quick approval of MAAs in the EU.
Freyr has very strong Regulatory team with expertise in compilation, review and submission of ASMFs to all the EU countries in line with country-specific submission procedures. With a strong footprint in handling ASMF submissions to EU countries for all types of APIs (manufactured by chemical/Fermentation/ biological/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 ASMF submission in line with current EU requirements/guidelines
- Compilation, review and submission of ASMFs for APIs in line with EU requirements
- Publishing of ASMF in eCTD/NeeS/PDF as per country-specific requirements
- 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 ASMFs for PAC and life cycle management (LCM)
- Preparation of Regulatory strategy and response to HA queries (RTQs) for quick approval of MAAs