Pharmaceutical equivalence

Abstract: The article discusses the possibility to derive the therapeutical equivalence of analogous composed herbal medicines from their pharmaceutical equivalence. Such considerations arise from the demands of the 5th amendment of the German Drug Law (Arzneimittelgesetz AMG). According to this amendment, the admission to the market requires a preparation-specific proof of the efficacy by means of costly clinical trials. Therefore a concept is presented by which the demands of the AMG, e. g. the product specific proof of efficacy and safety by clinical trials can be restricted to an ethically and economically acceptable extent. By means of this concept some of the phytomedicines which are in the late stage of the review process could be kept alive and must not be converted into traditionally used drugs or into drugs which lose their admission to the market in 2004.

Keyword(s): Therapeutical equivalence

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