Herbal drug preparations and products have a long tradition as medicinal products with different significance in the various Member States of the European Union. They are "medicinal products containing as active substances exclusively herbal drugs or herbal drug preparations".

If a plant product is categorised as a medicinal product, Directive 65/65/EEC fully applies and marketing authorisation is needed. With regard to good manufacturing practice (GMP) and quality control, the requirements of Directive 75/319/EEC apply in principle also to herbal medicinal products. Quality, safety and efficacy have to be documented according to Directive 75/318/EEC. In principle no difference is made in scientific requirements between medicinal products of herbal or chemical origin. Whether or not simplified procedures with respect to proof of efficacy are used, a complete documentation ensuring a sufficient level of quality has always to be provided.

Consequently herbal medicinal products, like chemical medicinal products, have to be documented according to the new Common Technical Document format in the future. Therefore the suitability of this format for herbal medicinal products has to be discussed, and if necessary adaptations made with respect to the peculiarities of these products.

The presented work was borne from intensive discussions within the company on how to structure the active substance part of the quality dossier of a herbal medicinal product. It was found to be difficult to extrapolate the requirements of the Notice to Applicants (as revised by EMEA/HMPWG/8/99) to practice, especially to decide which information to present in which section without the need of duplication. The introduction of the Common Technical Document with its more logical and modular structure provides the great chance to significantly improve these difficulties. The presented work reflects the experience gained with the compilation of three dossiers of herbal medicinal products for the German and European market which might not be representative for all such existing products world-wide.

The work concentrates on the quality part and especially on the "body of data", i.e. Module 3 of the Common Technical Document. Firstly a short overview of the history and present state of the Common Technical Document is given. Differences to the Notice to Applicants concerning quality are discussed. Then the work of the Herbal Medicinal Products Working Party (HMPWP) is briefly presented and existing specific guidance concerning the quality of herbal medicinal products summarised. A proposal for adaptation of Module 3 of the Common Technical Document to herbal medicinal products is discussed. The proposal itself is presented in the annex and makes comprehensive references not only to guidelines, but where possible also to specific sections of guidelines. Furthermore, not only ICH guidelines are referenced, but also regional (European) and some national (German) regulating documents.

The regulatory affairs field is developing rapidly. The presented work reflects the status as of March 2001.

Pages: 41