On 12 November 2009 the fnal "Guideline on Selection of Test Materials for Genotoxicity Testing for Traditional Herbal Medicinal Products / Herbal Medicinal Products" was issued. This document will become effective on 1 July 2010.
For evaluating the genotoxicity of herbal substances and preparations the HMPC Guideline from 2007 (EMEA/HMPC/107079/2007) can be applied.
In the creation of the collective list ("community list") of herbal substances, preparations and relevant combinations for use in traditional herbal medicinal products - compiled by the European Commission and based on suggestions from the HMPC - it has been proven that inclusion in this list is, in many cases, only unsuccessful due to missing data on genotoxicity.
It is the aim of this now approved guideline to present possible procedural methods with regard to which types of materials are to be used in genotoxicity testing. The guideline suggests that reduced test designs be applied, for instance the "bracketing / matrixing" approach, in which a few representative materials are to be tested, and not every manufacturer will be obliged to research their own specific preparations, as is normally the case in genotoxicity testing.
Consensus must be found with regard to which of the various test materials are to be regarded as representative for herbal substances and preparations which are usually used, with the aim of making their entry into the collective list easier ("community list").
These same procedural methods may also be selected for herbal products which fall into the category of "well-established use".
This guideline also paves the way for industrial groups who are considering working collectively on genotoxicity testing. This is also supported by the Committee on Herbal Medicinal Products (HMPC).
With the aid of two standard plants (Meliot herb and Passiflora herb) a possible procedural method for "bracketing / matrixing" is being identified.
See the complete document here.
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)