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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:
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The selection of markers has to be justified
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The markers are supposed to be appropriate for the intended
purpose
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The markers are supposed to connect steps of the production
process and quality control measures
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Markers are used for quantitative and qualitative purposes
and are important to link the active substance and the herbal medicinal
product
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Acceptance limits for content of a proposed marker should be
specified and justified
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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
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