Additional Guidance Document on Active Substance Master File (ASMF) published by EMA

Recommendation

10/11 October 2023
Vienna, Austria

Handling Changes and Variations

The European Medicines Agency (EMA) has published an additional Guidance document relating to Active substance Master Files (formerly known as European Drug Master File). The new document will complement the revised Guideline on Active Substance Master File Procedure which was published on 21 June 2012 and which came into force on 1 October 2012.

It is the intension of the ASMF procedure to allow valuable confidential intellectual property or 'know-how' of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or Marketing Authorisation (MA) holder to take full responsibility for the medicinal product, and the quality and quality control of the active substance. National Competent Authorities (NCA) / European Medicines Agency (EMA) thus have access to the complete information that is necessary for an evaluation of the suitability of the use of the active substance in the medicinal product.

The additional guidance document will provide guidance on completing the Annex 2-letter of access, Annex 3-submission letter and administrative details for documents relating to an active substance master file and Annex 4-withdrawal of access letter of the active substance master file procedure guidance (CHMP/QWP/227/02 Rev 3, EMEA/CVMP/134/02 Rev 03).

The objective of the Annexes is to assist National Competent Aufhorities/EMA identify and track where the same ASMF is used in multiple European (Centralised, Decentralised or Mutual Recognition) procedures and/or Member States. In addition the Annexes should facilitate sharing of the ASMF assessment report, with the ultimate aim of improving harmonisation of decision making and reducing the regulatory burden on ASMF and MA holders alike.

Source: Additional guidance on documents relating to an active substance master file