Contributions and visions of the Committee on Herbal Medicinal Products (HMPC)

Abstract

Medicinal plants have been used in health care since ancient times. Whereas therapeutic use of herbal medicinal products has a long tradition a formal regulation only started during last century. The European Union has established a common regulatory framework for (traditional) herbal medicinal products. Definitions and basic principles are laid down in Directive 2001/83 EC and its amendments. Quality, efficacy and safety of finished medicinal products have to be evaluated before being introduced into the market. Registration of traditional herbal medicinal products is simplified with respect to the proof of efficacy and data on safety. The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA) in London was established in 2004 and has developed guidance on assessment of (traditional) herbal medicinal products. One of the major tasks of the HMPC is to establish harmonised community monographs on safety and efficacy of herbal substances or combinations. About 130 monographs have been finalised until 2014, representing a substantial progress of harmonisation in the European Union. The development of community monographs is a transparent process which is offering options for scientific input by interested parties. After adoption a complete package of monograph, assessment report, overview of comments and list of references is published at the website of EMA (www.ema.europa.eu). Basically, the provisions of Directive EC 2004/24 offer also options for traditional herbal medicinal products originating from non-European therapeutic systems. Moreover, applicants may seek scientific advice preferably in early developmental stages of professional projects. The HMPC started in its working programme a pilot project on monographs on efficacy and safety of herbal substances of non-European origin. Questions & Answers on the European Union regulatory framework for (traditional) herbal medicinal products, including those from a 'non-European' tradition, have been adressed in a specific document. Communication, scientific research and regulatory dialogue are necessary to improve the options for a harmonised global usage of traditional medicines.