Regulatory Options for (Traditional) Herbal Medicinal Products

All over the world plants have been selected by people because of their healing properties. In Europe, first manuscripts describing medicinal plants were written more than two thousand years ago. Starting from this traditional use, which was often based on ready-to-use receipts, there was a development towards usage of finished herbal medicinal products in central Europe during the 20th century.

In parallel with an increasing scientific knowledge on medicinal plants – which included also the identification of highly active purified compounds of plant origin – a common regulatory environment for all medicinal products has been established in Europe. The basic regulatory approach is to control the access to the market and to assess quality, safety and efficacy of medicinal products in order to improve public health and to facilitate supply with medicinal products.

There is a clear European regulatory framework for medicinal products (directive 2001/83/EC as amended) providing basic definitions and offering two options to bring products into the market: i) registration of traditional herbal medicinal products and ii) marketing authorisation of herbal medicinal products. Beside applications at the national level there are also options for European procedures.

A harmonised scientific evaluation in this field is resulting from the work of the Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA). The major tasks are development of Community Monographs and List Entries on herbal substances as well as relevant guidance. These activities will facilitate handling of procedures and contribute to the harmonisation of the market.