Significant Administrative Changes in the New Revision of the Guideline on the ASMF Procedure

The Guideline on Active Substance Master File Procedure is an important document within the framework of a marketing authorisation. The ASMF describes the quality characteristics of the pharmaceutical API. The "closed part" or "restricted part" contains details about the synthetic procedure of API manufacturing, i.e. about the valuable confidential intellectual property of the API manufacturer, to which the applicant has no access. All the other information relevant for a marketing authorisation is to be found in the "open part" or "applicants' part" of the ASMF.

In the revision carried out in 2005, the particularities of herbal APIs in the human and veterinary field had been taken into account. The current revision dated from 12 January of this year aims at accomplishing an administrative harmonisation which should facilitate the processing of an ASMF by the European authorities. The objective is to improve the communication between the ASMF holder, the applicant and the European authorities to optimise the complete ASMF procedure. To this end, the existing annexes of the Guideline have been adapted and one annex has been added. The 7 annexes include the following topics:

  • Annex 1: Overview of the ASMF contents
  • Annex 2: Template letter of access to the restricted part of the ASMF (from the ASMF holder to the authority)
  • Annex 3: Template Submission Letter and Administrative Details for documents relating to an ASMF (from the ASMF holder to the authority)
  • Annex 4: Template Withdrawal of access letter to the restricted part of the ASMF (from the ASMF holder to the authority)
  • Annex 5: Presentation of cases of non-applicability of the ASMF procedure i.e. cases when the concept of restricted and open parts cannot apply (biological active substances, VAMF, PMF)
  • Annex 6: List of abbreviations
  • Annex 7: Glossary

On the long term, the objective of these administrative amendments is to have a unique version of an ASMF for one active substance valid for the whole EU/EEA, and consequently one AR of the ASMF recognized by all Competent Authorities.  

The present revision contains no changes which concern the ASMF procedure itself. That is why no concept paper had to be created and a consultation period of two months was considered reasonable. The deadline for comment is 12 March 2012.

Plaese see the revised Guideline on Active Substance Master File Procedure for further information.

Note: The ECA Conference "CTD, CEP and ASMF" on 17/18 April 2012 in Heidelberg, Germany, will focus on the particularities of the ASMF procedure.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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