Safety data for herbal medicinal products: Assessment of genotoxicity

The safety of herbal medicnal products (HMP) is usually supposed to be high, as it is documented by their long-standing therapeutic use. This view is generally accepted as far as it is based on endpoints which can be causally assigned to the product during clinical use. In the case of genotoxic effects this is not the case, as the manifestation of their consequences, as e.g. an enhanced incidence of cancer, would occur too late to allow an assessment of causality. Therefore, within the EU, an assessment of genotoxicity is a precondition for registration or approval of a HMP. The committee responsible for HMPs at the European regulatory agency EMA, HMPC, has therefore published guidelines [1,2] which support the assessment of the whole range of preparations available from a herbal drug by means of a bracketing and matrixing approach. With the aim of providing such data for the most important herbal drugs used in Europe, Kooperation Phytopharmaka, a scientific society in the field of HMPs, is conducting a cooperation project [3].

Up to now, data on more than 30 herbal drugs have been generated, including artichoce, birch, ginseng, hawthorn, hops, horse chestnut, milk thistle, passion flower, sage, stinging nettle, St Johns wort, thyme and valerian.

The project has addressed the question whether these herbs could be genotoxic and has generated data needed for regulatory submissions to drug regulatory agencies within the EU.

References:

[1] Guideline EMEA/HMPC/107079/2007.

[2] Guideline EMEA/HMPC/67644/2009.

[3] Kelber O., Steinhoff B., Kraft K., 2012. Assessment of genotoxicity of herbal medicinal products: A co-ordinated approach. Phytomedicine 19, 472, free access via http://www.koop-phyto.org