New EMEA Paper on Markers for Herbal Medicinal Products

 
On 10 January 2008 the European Medicines Agency (EMEA) issued the HPMC Document „Reflection Paper on Markers used for Qualitative and Quantitative Analysis of Herbal Medicinal Products and Traditional Herbal Medicinal Products“ as draft.

This paper is valid for markers used in the quantitative and qualitative analysis of herbal medicinal products. With regard to the special and complex nature of these products “markers can provide an option to ensure and demonstrate adequate and consistent quality of these products” as the paper states in its summary. The “Reflection Paper” proposes criteria that should be considered for the selection of analytical as well as for active markers.

Currently there are only very few indications with regard to the selection and the quality of markers. The selection and the quality documentation provided for markers, varies considerably between applicants/manufacturers – even for quite similar products.

The document’s conclusion contains basic principles that should be considered for the selection of markers. Among them are:
 

• The selection of markers has to be justified

• The markers are supposed to be appropriate for the intended purpose

• The markers are supposed to connect steps of the production process and quality control measures

• Markers are used for quantitative and qualitative purposes and are important to link the active substance and the herbal medicinal product

• Acceptance limits for content of a proposed marker should be specified and justified

• The mere determination of the stability of the marker will not suffice for proving the stability of the herbal medicinal product

In addition the document also contains further requirements for markers with regard to the qualitative und quantitative analysis. The document is concluded by a comprehensive list with definitions.

The complete document is available at:
http://www.emea.europa.eu/pdfs/human/hmpc/25362907en.pdf