The Pharmaceutical Journal
Vol 268 No 7183 p123-130
2 February 2002

This article
Reprint
Photocopy

News summary

Europe proposes registration procedure for herbal medicines

A specific registration procedure for herbal medicines with long-standing traditional use has been proposed by the European Commission. The rationale is to improve quality checks and market surveillance by creating a clear regulatory environment.

Demand for herbal medicines across the European Union is growing. However, the rules governing the placing on the market and surveillance of these products differ from one member state to another. This is believed by the Commission to have a detrimental impact on public health protection and on the free movement of goods.

The Commission proposal provides for a simplified registration system for traditional herbal medicinal products. The quality requirements are to be the same as for medicines, but instead of conducting tests and trials on the safety and efficacy of products, these are to be assessed on the basis of information gathered on traditional use over a period of at least 30 years.

The proposal also provides for a new scientific committee of herbal medicine experts to be established within the London-based European Agency for the Evaluation of Medicinal Products (EMEA)

One of the committee's major tasks will be to establish monographs that further harmonise and facilitate registration applications concerning herbal medicinal products.

Back to Top