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On 22 June 2006 EMEA published the Concept Paper on Quality of
Combination Herbal Medicinal Products/Traditional Herbal Medicinal
Products.
Drafting the EMEA Guidelines on Quality of Herbal Medicinal Products
and on Specifications of Herbal Medicinal Products (see GMP
news from 21 August) it showed that the regulations of existing
Guidelines on Quality of Herbal Medicinal Products is not sufficient for
complex, compound herbal products. The complex composition of combination
herbal medicinal products generates additional challenges to demonstrate
and to proof the quality of combination products.
For that reason the Committee on Herbal Medicinal Products (HMPC)
recommends to develop a separate Guideline on Quality of Combination
Herbal Medicinal Products. The pharmaceutical industry is invited to
forward proposals and comments with regard to the planned document.
The complete document is available here:
http://www.emea.eu.int/pdfs/human/hmpc/5822206en.pdf
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