Active Substance Master File (ASMF) Submissions

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Active Substance Master File submission (ASMF submission) is not a mandatory requirement from the European Union (EU) Health Authorities, as it would be reviewed only in connection with a Marketing Authorization Application (MAA). Active substance (API) manufacturers/Active substance Master File holders can directly submit the Active Substance Master File (ASMFs) to the EU Health Authorities as per the submission procedure identified by the MAA holder.

To avoid administrative comments/rejection of MAA due to non-availability of the ASMF and to receive timely MAA approval, submission of ASMF as per the EU specific requirements (ASMF guidelines) is very critical. ASMF holder can provide Letter of Authorization (LoA) to multiple MAA holders to refer in multiple applications. Freyr’s expertise in handling the ASMF submissions and its life cycle management include:

Freyr Expertise and Advantages

Freyr Expertise

  • Support in identifying the Regulatory starting material and Intermediates
  • Guidance on selecting 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 Substance
  • Support in setting the control strategy and limits for genotoxic impurities and elemental impurities in intermediates or in 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 submission of ASMF to avoid any delays
  • Publishing ASMFs in eCTD format as per current EU guidelines
  • Regulatory strategy, preparation and submission of Variations and renewals for already registered ASMFs
  • Regulatory strategy and preparation and submission of response to the Health Authority queries