Dr Konstantin Keller, Germany

The herbal medicines market in the European Union (EU), which is currently worth about US $3 billion and growing, is dominated by Germany and France. In some countries, the majority of these herbal medicines are prescribed by conventionally trained medical doctors, mostly general practitioners.

There are two different approaches to assessment of herbal medicines in Europe. One is through the European Pharmacopoeia, which includes two groups of herbal medicines. The European Pharmacopoeia provides standards for:

• production of herbal drugs by the pharmaceutical industry;
• quality control laboratories;
• regulatory authorities; and
• community pharmacists.

The second approach is through the EMEA in London, England. A permanent working party was established in EMEA and became a permanent working party of the Committee for Proprietary Medicinal Products (CPMP). The working party has the responsibility to:

• develop new guidance on quality, safety and efficacy of herbal medicines, and common criteria for interpretation;

• form and regularly update a common understanding of existing legislation and guidelines.

The following quality guidance documents for herbal medicinal products were submitted for scientific review by the Quality Working Party and endorsed by CPMP:

• Notes for Guidance on Quality of Herbal Medicinal Products;
• Notes for Guidance on Specifications;
• Notes for Guidance on Quality of Water for Pharmaceutical Use.

Guidance on Good Agricultural and Collection Practice for Starting Materials of Herbal Origin and Guidance on the Assessment of Safety/Pharmacovigilance are also under consideration.

Currently, in the European Union, there are two ways to submit data on the safety and efficacy of herbal medicinal products. For herbal medicinal products that have not previously been marketed in the EU, or for a new therapeutic use of an existing product, full documentation on new tests and trials must be provided, as required for any new drug application. For established products that have already been on the market in the EU for at least 10 years, full bibliographic documentation is needed.

The European Commission has proposed new legislation on traditional herbal medicinal products, which is still in draft form. The main provisions in the draft legislation are:

• herbal medicinal products may only be used orally, externally or for inhalation;

• there should be a history of at least 30 years of traditional use (at least 15 years within the EU and 15 years outside);

• there must be sufficient data on traditional use and the products should not be harmful;

• the only indications allowed are those that do not require the intervention of a medical practitioner for diagnosis or monitoring;

• efficacy must be plausible on the basis of long-term use and experience;

• there must be specific labelling that the product has not been clinically tested.

A committee for traditional herbal medicinal products at the EMEA will establish community herbal monographs with full information on certain herbs and lists of traditional uses of herbal substances.

With regard to quality, a full documentation dossier will be required for traditional herbal medicines, equal to that for full registration. Regarding safety and efficacy, a bibliographical review of safety data and bibliographical or expert evidence on traditional use for at least 30 years will be required. However, this evidence will not be required for products that are included in the lists or covered by the monographs published by the committee.

Thus, the legal framework within the EU has been consolidated, with a specific expert committee for herbal medicines. In future there will be three types of documentation: full documentation, bibliographic documentation and traditional documentation. We will also have two procedures: normal marketing authorization and registration of traditional herbal medicinal products.