Masterstudiengang "Drug Regulatory Affairs"


Regulatory Enviroment for Traditional Herbal Medicinal Products in the European Union ***

Rika Kremmer (Abschlußjahr: 2003)

Traditional herbal medicinal products which are characterised by being in use over a long period are mostly highly appreciated by the public. The existing European legal framework for medicinal products is mostly unsuitable for such products. Demonstrating well established use is often difficult due to a lack of sufficient published scientific literature. Also demonstrating safety and efficacy with new studies seems inappropriate, as the nature of traditional use of the medicinal product often may allow conclusions on its safety and efficacy. Furthermore, it would lead to significant financial burden for the companies concerned.

Until now this specific situation of traditional medicinal products has not been considered in the European legislation and therefore, the Member States have established their own national regulations based on local traditions and cultural particularities. The motivation behind such initiatives was to keep products which, despite of their medical tradition, have insufficient proven efficacy, on national markets.

This heterogeneous regulatory situation in the field of traditional medicinal products lead to a negative impact on the free movement of goods and on the protection of public health within the European Community.

In order to improve the completion of the European single market, both the authorities and the pharmaceutical industry realised the need to harmonise the regulatory enviroment for herbal medicinal products, especially with traditional use. Therefore a proposal for amending the Directive 2001/83/EC as regards traditional herbal medicinal products has been developed by the European Commission. Besides definitions for herbal medicinal products, the draft directive proposes a simplified registration procedure for traditional herbal medicinal products and the creation of a new EMEA committee exclusively responsible for all matters of herbal medicinal products.

Through the establishment of a harmonised regulatory enviroment the current existing uncertainties concerning the status of the traditional products will be removed and the union of the European market will be facilitated.

The thesis will give an overview on the regulatory situation and the coming developments in the field of traditional herbal medicinal products in Europe.