EU to harmonise registration of traditional herbal medicines

The European Commission is to propose a specific registration procedure for herbal medicinal products with a long-standing traditional use in a bid to improve quality checks and market surveillance.

The Commission said that creating a clear and reliable regulatory environment for these products should benefit both patients and manufacturers, most of which are small- and medium sized enterprises (SMEs).

Demand for herbal medicines is growing continuously across the European Union. However, the rules governing the placing on the market and surveillance of these products differ from Member State to Member State. This has a detrimental impact on public health protection standards and the free movement of goods within the Union.

The Commission proposal, which takes account of several European Parliament and Council resolutions, provides for a simplified registration system for traditional herbal medicinal products.

The quality requirements are identical to those for all medicinal products. But instead of conducting new tests and trials on the safety and efficacy of the product, these can be assessed on the basis of the information gathered on its traditional use over a period of at least 30 years. Some of this use may have partially taken place outside the EU.

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