New Q&A Document of the CMDh gives Answers to Essential Questions on the ASMF Procedure

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23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

The Co-ordination Group of Mutual Recognition and Decentralised Procedures (CMDh) has published a Questions & Answers document regarding the Active Substance Master File (ASMF) procedure. In this document, the CMDh has clariified some issues which were still open and essential for the ASMF holder and the applicant in connection with the ASMF procedure and the submission of changes in the context of a marketing authorisation procedure.

The document is composed of 15 questions/ answers about the following sub-areas:

• Communication between the EMA/ competent authorities, the ASMF holder and the applicant.
• The EU-numbering system for ASMFs
• Accepted ASMF formats
• Several ASMFs for the one single active substance
• Withdrawal of a marketing authorisation/application

In the following, a few examples of questions are listed with the corresponding summarised answers:

• Question: The "Guideline on Active Substance Master File Procedure" (CHMP/QWP/227/02 Rev 3/Corr) became effective on 1 October 2012. Did the single ASMF numbering system also become obligatory from that date onwards?
  Answer: No. The pilot phase for this numbering system will start on 1 December 2013.
• Question: Does the ASMF holder have to change or adapt his own numbering system?
  Answer: No. The document control system specific to a company can be maintained. The new EU/ASMF number is an administrative tool for Competent Authorities to identify and track where the same ASMF is used within the different EU Member States.
  
• Question: How should an update to an ASMF be communicated to a Competent Authority?
  Answer: The ASMF holder has to inform the concerned marketing authorisation holder(s) about any changes to the ASMF. The marketing authorisation holders have to submit a variations application to the Competent Authority. At the same time, the ASMF holder needs to submit the relevant sections of the ASMF (AP and/or RP) to the Authority.
  
• Question: Can one ASMF holder have several ASMFs for the same active substance but with different synthetic routes (with deviating specifications or another purity grade)?
  Answer: Yes, provided that the routes of synthesis and the resulting quality characteristics of the active substance differ significantly. Otherwise, there should be only a single ASMF. Moreover, one should consider that only one version of an ASMF is to be used in marketing authorisation applications and authorisations in Europe.

The exact Q&As as well as more questions and answers are available in the Questions & Answers document regarding the Active Substance Master File (ASMF) procedure. More information about the procedure of the numbers attribution for ASMFs - as requestable from the 1st of December 2013 - as well as about the work-sharing procedure for the assessment of ASMFs can be found on the "Working Group on Active Substance Master File Procedures" page of the CMDh website.