Active Substance Master File Guideline in Revision

GMP News No. 852

GMP News
7 December 2006

Active Substance Master FileGuideline in Revision

The GUIDELINE ON ACTIVE SUBSTANCE MASTER FILE PROCEDURE is currentlybeing revised. The deadline for commenting it ended on 30 August 2006,thus the new guideline should be published soon. With regard to thebackground for the revision the current draft points out that:

"From 1st November 2005, Directive 2004/24/EC1 relating totraditional herbal medicinal products came into force in all MemberStates in the European Union allowing the establishment of a simplifiedprocedure for the registration of traditional herbal medicinal productsfor human use.

In order to facilitate the use of the ASMF procedure in the area ofherbal medicinal products, the Committee for Herbal Medicinal Productsproposes an Annex on herbal substances/preparations (see Annex 1, table3) to the Guideline on the Active Substance Master File procedure.

It should be noted that the principles which are outlined in thisguideline in relation to traditional herbal medicinal products areequally applicable to other herbal medicinal products, both for Humanand Veterinary use, which do not follow the simplified registrationprocedure. The new table (Annex 1, table 3) takes into account theparticularities of herbal substances/preparations whilst alsohighlighting that this procedure is/can be applied to activesubstances/preparations of herbal origin, whether they be for human orveterinary use.

Since this revision introduces clarification rather than changingprinciples, the publication of a concept paper was not considerednecessary.

The final Guideline has been adapted to the new template forGuidelines."

Format, content and submission procedures for thepharmaceutical documentation of the drug substance quality for differenttypes of dossiers like the CTD, the CEP and the European ASMF as well asthe US-DMF are also covered during the European Compliance Academy'seducation course

CTD, CEP and ActiveSubstance Master File

– in Barcelona,Spain, from 26-27 March 2007.
Prepared by:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)


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