title: Requirements on efficacy of herbal medicinal products.
abstract: Based on the regulatory requirements on efficacy documentation in the European Union, the herbal medicinal products have been grouped into the following sections: (i) Herbal medicinal products for which the efficacy is demonstrated by results of a "full" set of clinical trials that are in conformity with the relevant guidelines of the therapeutic area in question. This regulatory pathway to obtain a marketing authorisation for a new medicinal product (new chemical entity) is open to herbal medicinal products, but the examples are in reality few. (ii) Herbal medicinal products which have a "well-established medicinal use with a recognised efficacy and an acceptable level of safety" in the European Union. Results of new and product specific clinical trials are not required to obtain a marketing authorisation for products that fulfil these criteria, but a substantial clinical experience must be documented and sufficient scientific data on efficacy must be publicly available. (iii) "Traditional" herbal medicinal products, that do not fulfil the efficacy requirements for a marketing authorisation, but for which a medicinal use of at least 30 years including 15 years in the European Union can be documented. Traditional herbal medicinal products can only be registered with therapeutic indications that are considered safe for use without the supervision of a physician. After briefly reviewing the regulatory requirements on efficacy documentation of herbal medicinal products in the European Union, some concluding remarks on the past and future developments in the area are made.
authors.affiliation: Medical Products Agency, P.O. Box 26, 751 03 Uppsala, Sweden. Electronic address: per.claeson@mpa.se.
authors.forename: Per
authors.initials: P
authors.lastname: Claeson
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D008519:Medicine, Traditional / Q000592:standards*; D008517:Phytotherapy / Q000592:standards; D028321:Plant Preparations / Q000592:standards*; D013997:Time Factors
chemical_list: D028321:Plant Preparations
keywords: Clinical trials; Efficacy; Herbal medicinal products; Traditional use; Well-established medicinal use