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European Drug Master File (EDMF)


European Drug Master File (EDMF) also known as Active Substance Master File (ASMF) is 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 Authorization (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance.

Content of the EDMF/ASMF

1. General information

  • Nomenclature
  • Structure
  • General properties

2. Manufacture

  • Manufacturer(s)
  • Description of Manufacturing Process and Process controls
  • Control of Materials
  • Control of critical steps and intermediates
  • Process validation and/or Evaluation
  • Manufacturing Process Development

3. Characterization

  • Elucidation of Structure and other Characteristics
  • Impurities

4. Control of Drug Substance

  • Specification
  • Analytical procedures
  • Validation of analytical procedures
  • Batch analysis
  • Justification of specification

5. Reference standards or materials

6. Container Closure System

7. Stability

  • Stability summary and conclusion
  • Post-approval Stability Protocol and Stability Commitment
  • Stability data

An ASMF can only be submitted in support of a Marketing Authorization Application (MAA) or Marketing Authorization Variation (MAV). The relationship between the quality of the active substance and its use in the medicinal product needs to be justified in this MAA or MAV.

Required Documents for Submission

  • Letter of Access
  • A copy of the Expert’s curriculum vitae
  • QOS or detailed and critical summary, as appropriate
  • Table of Changes (only for submission of an update to a currently authorized ASMF)
  • A copy of the proposed ASMF holder’s active substance specification 
  • A copy of the ASMF Deficiency Letter sent by Competent
  • Authority/EMA (only for submission of response documents)
  • Correlation table for CTD: NtA formats

The scientific information in the ASMF should be physically divided into two separate parts, namely the Applicant’s Part (AP) and the Restricted Part (RP). The AP contains the information that the ASMF holder regards as non-confidential to the Applicant/MA holder, whereas the RP contains the information that the ASMF holder regards as confidential. It is emphasized that the AP is still a confidential document that cannot be submitted by anyone to third parties without the written consent of the ASMF holder.

As for medicinal products, ASMF holders should keep the content of their ASMFs updated with respect to the actual synthesis/manufacturing process. The quality control methods should be kept in line with the current regulatory and scientific requirements. ASMF holders shall not modify the contents of their ASMF (e.g. manufacturing process or specifications) without informing each Applicant/MA holder and each National Competent Authority/EMA.

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Reference: European Medicines Agency (EMA)

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