ASMF/CEP Submissions - Overview
Active Substance Master Files (ASMFs) contain detailed information on the manufacture and properties of active substances and are, therefore, valuable and confidential. The ASMF ensures the protection of the manufacturer’s intellectual property and allows applicants and Marketing Authorization Holders (MAHs) to undertake responsibility for the medicinal product and the quality of the active substance.
Active Substance Master Files should be presented in the CTD format and are usually divided into two (02) separate parts based on the confidentiality of the content. Information that is considered by the ASMF holder to be non-confidential to the applicant/MAH is contained in the Applicant’s Part (AP), and information considered to be confidential is included in the Restricted Part (RP). The EMA guideline on the Active Substance Master File procedure must be followed to submit ASMFs in compliance with Health Authority (HA) requirements. The submissions must be accompanied by other documentation as specified in the guideline (e.g., Quality Overall Summary (QOS) and Letter of Access).
Manufacturers of substances in the European Pharmacopoeia (Ph. Eur.) can apply for a Certificate of Suitability (CEP). The EDQM guidance on the process for applying for a Certificate of Suitability (CEP). includes the submission of a CTD formatted dossier and a QOS. If a CEP is available for an active substance, companies can use this document instead of an ASMF, thus simplifying the active substance documentation required for medicinal product applications. This can also streamline some active substance-related post-approval changes that can arise during the lifecycle of the product.
Freyr’s Regulatory expertise in the compilation, review, and submission of Active Substance Master Files (ASMFs) and Certificate of Suitability (CEP) submission process in line with the EU and national submission procedures makes it a preferred Regulatory partner for Active Pharmaceutical Ingredients (APIs) and medicinal product manufacturers.
ASMF/CEP Submissions - Expertise
- Identifying the starting materials.
- Designing limits for impurities in starting materials, intermediates, and their potential carry-over to drug substances.
- Designing specifications and in-process limits for starting materials, intermediates, and drug substances.
- Setting the strategy and limits for genotoxic impurities and elemental impurities in intermediates or drug substances.
- Guidance on designing the protocols for stability studies, process validation, hold-time studies, and forced degradation studies.
- Gap analysis of source documents/data generated for ASMF submissions in line with the current guidelines.
- The preparation and submission of ASMFs and Certificate of Suitability (CEP) applications (including support for the CEP sister-file procedure).
- Publishing of ASMFs and EU CEP applications in the eCTD format as per the current guidelines and requirements.
- Lifecycle management and maintenance of the existing ASMFs and CEPs.
- Regulatory strategy support, including preparation and submission of responses to HA queries.
