Active Substance Master File Submissions - 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:
Active Substance Master File Submissions
- 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.
- 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.
