Regulatory framework
Herbal medicinal products, like all medicinal products, are subject to pre-marketing authorisation. According to the German Medicines Act (Arzneimittelgesetz, AMG), the national regulatory authority (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is obliged to assess medicinal products for their quality, efficacy and safety before they are placed on the market. The AMG distinguishes between herbal medicinal products with recognised medicinal use and traditional herbal medicinal products.
Herbal medicinal products with recognised medicinal use
Herbal medicinal products with a well-established medicinal use according to Directive 2001/83/EC, also known as “rational” herbal medicinal products, base their efficacy in curing and alleviating diseases on the principles of science and evidence-based medicine. Efficacy and safety must be proven by clinical studies that meet certain criteria, or corresponding bibliographic material. This means that these herbal medicinal products are subject to the same requirements as chemical medicinal products. The documented scientific evidence to be submitted includes the documentation of efficacy and safety, including the pharmacological activity profile and pharmacodynamics, toxicology and, as far as possible, pharmacokinetics.
Traditional herbal medicinal products
In 2005, in implementation of European law, the legislator made it easier to place herbal medicinal products on the market by introducing a registration procedure for those products that have a long tradition and a proven safety. As proof of efficacy, bibliographic information on traditional use over 30 years must be submitted, and the pharmacological effects/efficacy of the product must be plausible on the basis of long-term use and experience. In contrast to the indications of “rational” herbal medicinal products based on clinical studies or bibliographic data, the indications of a traditional herbal medicinal product are introduced with a statement that the use in specified indications is exclusively based upon long-standing use.
