Herbal medicinal products in the EC; indications versus claims; an up-to-date scientific view

Abstract

All over the world medicinal plants have been used in health care since ancient times. Even though selection and documentation of manifold receipts have a long tradition, the formal regulation of herbal medicinal products (HMPs) is newer. The aim of this presentation is mainly to discuss the implementation of the current European regulations at the level of EU authorities in terms of quality, safety and efficacy of herbal products through the HMPs Directive (2004/27EC amending Directive 2001/83/EC as regards Traditional Herbal Medicinal Products (THMPs) and Well Establish Use products (WEU). The Herbal Medicinal Products Committee (HMPC) at the European Medicines Agency (EMA) has adopted guidelines which are intended to support assessment of HMPs considering their particular characteristics. One of the major tasks of the HMPC is to establish community monographs and list entries of herbal substances or combinations. The development of such documents leads to a more harmonised view of the member states and at the end it should ideally generate a common market of HMPs. Currently, about 114 monographs have been finalised and the regulatory framework differentiates between marketing authorisation of HMPs and registration of THMPs, for which the efficacy must be plausible based on their long-standing use instead of being proven by clinical trials. In many cases, the distinction between THMPs and food supplements containing herbal products without nutritional value but having physiological effects, remain difficult and controversial. Borderline products, as well as advantages and disadvantages of both uses (as medicines and nutritional with health claims), have to be pointed out, as well as the consumers protection. A viewpoint of the regulatory Authorities Experience will be discussed in details, through several examples as well as the legal situation in the EU regarding their uses.