Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory requirements of the quality of traditional herbal medicinal products and the resulting challenge for the pharmaceutical industry ***

Dr. Kim Wuthold (Abschlußjahr: 2009)

Language: English

In Germany and some other EU member states, herbal remedies enjoy great popularity, particularly in the over-the counter sector. Many herbal medicinal products have a long tradition in these countries.

The "traditional-use registration" was established for traditional herbal medicinal products which fulfil the criteria laid down in Directive 2001/83/EC article 16, as amended by Directive 2004/24/EC article 16a (1). The special, simplified registration procedure should be used only where no marketing authorisation can be obtained pursuant to Directive 2001/83/EC, in particular because of a lack of sufficient scientific literature demonstrating a well-established medicinal use with recognised efficacy and an acceptable level of safety. Despite the fact that the tight definition of traditional herbal medicinal products limits the number of possible submission, since now more than 300 applications were submitted to the German authority.

The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience. Additionally, full pre-clinical tests are not necessary. It is said that where the medicinal product on the basis of the information on its traditional use proves not to be harmful in specified conditions of use, full pre-clinical tests could be omitted. However, even a long tradition does not exclude the possibility that there may be concerns with regard to the product's safety, and therefore the competent authorities is entitled to ask for all data necessary for assessing the safety. At minimum, genotoxicity data are required.

The quality aspect of the medicinal product is independent of its traditional use so that no derogation is been made with regard to the necessary physico-chemical, biological and microbiological tests. Products should comply with quality standards in relevant European Pharmacopoeia monographs or those in the pharmacopoeia of a member state.

Having in mind the particular requirements of these medicinal products, especially the possibility to reduce or omit the expensive pre-clinical and clinical testing, the simplified registration procedure for traditional herbal medicinal products is well accepted by the pharmaceutical industry. First experience could be collected by the national authorities so that more and more guidelines also take the traditional herbal medicinal product into consideration.

Nevertheless, it is a challenge for the pharmaceutical industry to fulfil the requirements of current quality guidelines for traditional herbal medicinal products which pharmaceutical development dates back more than 30 years.

Pages: 37,
Annexes: 4 pages