Active Substance Master File Guideline in Revision

GMP News No. 852

GMP News
7 December 2006
 

Active Substance Master File Guideline in Revision

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

"From 1st November 2005, Directive 2004/24/EC1 relating to traditional herbal medicinal products came into force in all Member States in the European Union allowing the establishment of a simplified procedure for the registration of traditional herbal medicinal products for human use.

In order to facilitate the use of the ASMF procedure in the area of herbal medicinal products, the Committee for Herbal Medicinal Products proposes an Annex on herbal substances/preparations (see Annex 1, table 3) to the Guideline on the Active Substance Master File procedure.

It should be noted that the principles which are outlined in this guideline in relation to traditional herbal medicinal products are equally applicable to other herbal medicinal products, both for Human and Veterinary use, which do not follow the simplified registration procedure. The new table (Annex 1, table 3) takes into account the particularities of herbal substances/preparations whilst also highlighting that this procedure is/can be applied to active substances/preparations of herbal origin, whether they be for human or veterinary use.

Since this revision introduces clarification rather than changing principles, the publication of a concept paper was not considered necessary.

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

We compared the currently valid with the draft guideline.

This comparison can be found here.

 
Format, content and submission procedures for the pharmaceutical documentation of the drug substance quality for different types of dossiers like the CTD, the CEP and the European ASMF as well as the US-DMF are also covered during the European Compliance Academy's education course

CTD, CEP and Active Substance 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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