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Regulatory Focus™ > News Articles > EMA Releases New Guideline on Active Substance Master File Procedure

EMA Releases New Guideline on Active Substance Master File Procedure

Posted 20 January 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency released its Guideline on Active Substance Master File (ASMF) Procedure yesterday that aims to improve the ASMF procedure across the European Regulatory Network by having a unique version of an ASMF for one active substance valid for the whole European Union (EU) and European Economic Area (EEA). One assessment report (AR) of an ASMF can be recognized by all Competent Authorities (CAs), thereby improving a product's time to market.

The purpose of the ASMF is to allow manufacturers to share confidential data with National Competent Authorities by restricting access to part of the document. For human medicinal products being submitted in the form of an electronic Common Technical Document (eCTD), these parts are referred to as the Applicant's Part (AP) and the Restricted Part (RP). The AP is non-confidential, but release of the document still requires the consent of the ASMF holder. The RP is confidential and typically contains proprietary information about the product and its manufacturing processes, including reaction conditions, temperature, and validation and evaluation data of critical steps.

Both the AP and RP should contain a table of contents and a summary of the Part. If a summary is contained within an eCTD, it should be presented as a Quality Overall Summary (QOS). Veterinary products will have a separate format, found in Annex 1, Table 2 of the guideline.

An ASMF may be used for new or existing active substances, including herbal active substances or preparations. Updates made to one ASMF should be made to the ASMF's of all National Competent Authorities.

EMA notes in the guideline that the revision is mainly administrative in nature, and stakeholders have already been consulted with extensively. This guideline replaces guideline CPMP/QWP/227/02 Rev 2 (EMEA/CVMP/134/02 Rev.2).  Comments are due by 12 March 2012.

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