New legislation to simplify registration of traditional medicines

Bea Perks/London, UK

The European Medicines Agency (EMEA) has launched a committee to guide member states and European institutions on the use of herbal medicinal products. The Herbal Medicinal Products committee had its first meeting at the end of September, and will now start to tackle the issue of facilitating a new EU legislative framework governing traditional herbal remedies.

A herbal directive has been drawn up by the European Parliament with the aim of streamlining the authorisation of herbal medicinal products across the EU. It introduces a simplified registration procedure for these products, and recognises that long-term use and experience do away with the need for pre-clinical tests or the results of clinical trials.

Long-term use in this regard means that a product must have been in medicinal use for at least 30 years, including 15 years in the European Community (15 years was arrived at following a protracted debate over the use of non-European traditional medicines). The directive covers products containing herbal substances, herbal preparations, or a combination of both, although this may be reviewed later to include ingredients such as minerals, vitamins or animal parts. Any review will have to wait, however, until an initial report of the simplified registration procedure has been completed in 2007. There are no EU wide legislative provisions to prohibit or restrict the use of herbals in food supplements.

The role of the committee will be to provide scientific guidance on issues relating to the legislation, and to establish a list of herbal substances, preparations and combinations, and the elaboration of Community herbal monographs. If a product is on the list or covered by a Community monograph, applications for registration will only have to demonstrate a product's quality.

'I am personally convinced that the work of the new committee will be successful and that there will be a much wider availability of safe herbal medicinal products of high quality in the years to come,' said Dagmar Roth-Behrendt, vice president of the European Parliament who was instrumental in drawing up the directive, which member states must adopt by October 2005.