National practice: Experiences with the safety assessment for (traditional) herbal medicinal products

Abstract

Herbal medicinal products (HMPs) are highly accepted in many Member States of the European Union, even though their specific regulatory status may be different. In contrast to other medicinal products HMPs have particular characteristics, which should be additionally considered in assessment of safety. Generally there are no exceptions in the European legislation with respect to the preclinical safety evaluation of HMPs. Nevertheless, when applying the legislation a reasonable adaptation to cover the particulars of HMPs (e.g. testing strategies) is inevitable. The Committee on Herbal Medicinal Products (HMPC) was established at the European Medicines Agency (EMA) to generate a harmonised view an all issues concerning HMPs. Within this work the HMPC adopted a series of guidance documents referring to the safety of HMPs (e.g. general guidance on safety assessment, papers on specific issues like toxicity of defined natural products etc.). With respect to the traditional use of herbal medicinal products there is an option to reduce the set of tests to be performed in the context of preclinical testing. Nevertheless, experiences of the German national competent authority considering more than 300 applications in the field of traditional herbal medicinal products showed that consideration of the particulars of herbal medicinal products does not only open the chance to reduce the preclinical testing adequately but also provokes some additional questions which should be addressed case by case.