Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Registration of Herbal Teas as Traditional Herbal Medicinal Products according to §§39a-d AMG ***

Dr. Andrea Aschenbrenner (Abschlußjahr: 2011)

Language: English

Herbal teas are some of the oldest remedies for minor ailments. As a typical borderline product, the demarcation betweeen foodstuff herbal tea and medicinal herbal tea is difficult. The situation has become even more unclear with the introduction of Regulation (EC) No 1924/2006 on “food with a health claim”, to the extent that a court may ultimately have to decide wether a particular herbal tea is to be classified as food with a health claim or herbal medicinal product.

There are several legal possibilities of placing a medicinal herbal tea on the market. From the theoretical possibilities for obtaining a marketing authorisation, the well-established use application according to Art. 10a of Directive 2001/83/EC seems the only realistic option for a herbal tea in practice. The German drug law additionally offers the possibility of marketing herbal teas according to Standard Marketing Authorisations (Standardzulassungen). A simplified registration procedure for traditional herbal medicinal products was incorporated into European drug law with Directive 2004/24/EC. This procedure is highly suitable for medicinal herbal teas, as they are typically products with a long tradition of use, but little high quality scientific data on safety and efficacy, as would be required for a Art. 10a application.

However, proving the traditional use is not quite as straightforward as one might expect, especially in case of combination teas. Even though herbal teas have been in medicinal use for centuries, the qualitative and quantitative combinations for the same indications as well as the posology are subject to large variabiltiy.

Module 2 of a THMP dossier needs to include a proof of traditional use, as well as an overview of the available literature data on safety and efficacy. Module 3 underlies the same quality requirements as any other herbal medicinal product, but some aspects of the quality dossier are specific for herbal teas.

This applies to the demarcation of herbal substance and herbal preparation, where the definitions given in the guidelines and in Ph. Eur. are somewhat contradictory. The correct definition, however, is a pre-requisite for the entire documentation.

This thesis also gives detailed information on those chapters of module 3 which are of particular interest. The documents and information to be supplied in the chapters on manufacture (3.2.S.2 and 3.2.P.3) are described, as well as criteria for classifying a herbal substance / herbal preparation as excipient rather than as active substance. The specific requirements for the setting of specifications for a herbal substance, a herbal preparation and a herbal tea are also described and examples are given for each. Special emphasis is made on the challenges of determining the content of a herbal combination tea. Finally, the different aspects of stability testing of a herbal tea are highlighted.

Pages: 61