Traditional use as a regulatory category – experiences in Europe

Directive 2004/24/EC established a regulatory pathway for traditional herbal medicinal products in the European Union that allows the registration and marketing without the standard clinical data packages on safety and efficacy as required for other medicinal products. Five main criteria have to be fulfilled to guarantee safety in specified conditions: (1) indications suitable for self medication, (2) specified strength and posology, (3) appropriate route of administration, (4) a minimum 30 years period of traditional use and (5) sufficient data to prove that a product is not harmful in specified conditions and effects are plausible based on long-standing use and experience. Thus, the traditional use in the regulatory sense comprises well-defined restrictions that deviate from the concept of traditional use in sensu lato but also standard information generated in ethnopharmacological research.

The necessary documentation for compliance with the five criteria are presented using examples of herbal substances from monographs as published by the Committee on Herbal Medicinal Products at the European Medicines Agency. Typical issues of data generation and availability are demonstrated. It is further discussed why not all types of traditionally used medicines or derived preparations fit into the current regulatory framework – even if scientific and historic evidence is available. Conclusions are drawn on the opportunities and limits for use of ethnopharmacological research data for regulatory purposes.