Active Substance Master File, ASMF Submissions, APIs, MAA, EDQM, EU

Freyr helps in Active Substance Master File (ASMF) compilation, review and submission to all the EU countries with specific submission procedures for all the types of API (manufactured by chemical/Fermentation/ biological/sterile)/drug Substance.

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.

Know more at Freyr page - Active Substance Master File (ASMF) Submissions

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