Active Substance Master File (ASMF) Submissions

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Active Substance Master File (ASMF) Submissions – An Overview

An Active Substance Master File (ASMF), formerly known as European Drug Master File (EDMF) submission, is not a mandatory requirement for the European Union (EU) Health Authorities (HAs), as it is reviewed only in connection with a Marketing Authorization Application (MAA). Active substance (Active Pharmaceutical Ingredient [API]) manufacturers/Active Substance Master File holders can directly submit the ASMFs to the EU HAs as per the submission procedure identified by the MAA holder.

To avoid administrative comments/rejection of an MAA due to the non-availability of the ASMF and to receive timely MAA approval, submission of the Active Substance Master File as per the EU-specific requirements (ASMF guidelines) is crucial. The ASMF holder can provide a Letter of Authorization (LoA) to multiple MAA holders as a reference in multiple applications. Freyr’s expertise in handling the ASMF submissions and their lifecycle management is listed below:

Freyr Expertise and Advantages

Active Substance Master File (ASMF) - Freyr Expertise

  • Regulatory support in identifying the starting material and intermediates.
  • Active Substance Master File Procedure.
  • Guidance on selecting the route of synthesis for APIs.
  • Support in designing the limits for impurities in starting materials, intermediates, and their carry-over to APIs.
  • Designing specifications for starting materials, in-process, intermediates, and active substances.
  • Offering support to an ASMF holder in setting the control strategy and limits for genotoxic impurities and elemental impurities in intermediates or in the active substance.
  • Guidance on designing the protocols for stability studies, process validation, hold-time study, and forced degradation studies for ASMF submission.
  • Review of manufacturing details of starting materials for adequacy in ASMF.
  • Preparation, review, and Active Substance Master File submission to avoid any delays.
  • Publishing EMA’s ASMFs in the eCTD format as per the current EU guidelines.
  • Regulatory strategy, preparation, and submission of variations and renewals for registered ASMFs.
  • Regulatory strategy, preparation, and ASMF submission responses to HA queries.

Active Substance Master File (ASMF) - Freyr Advantages

  • ASMF Submission.
  • ASMF Procedure.
  • European Drug Master File (EDMF).
  • Active Substance Master File Guidance.
  • Guideline on Active Substance Master File Procedure.
  • ASMF Guideline.
  • Active Substance Master File Submission.
  • Active Pharmaceutical Ingredient Approval.