EMEA plans Guideline on Quality of Combination Herbal Medicinal Products

GMP News No. 795

GMP News
20 September 2006
 

EMEA plans Guideline on
Quality of Combination Herbal Medicinal Products

 
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
   

European Conference on Herbal Medicinal Products in Berlin:

The quality of herbal medicinal products is also the focus of the Conference
"Quality Aspects of Herbal Medicinal Products" in Berlin on 8/9 November 2006.

A visit of the production and laboratory facilities of ad.de (former Lichtwer) in Berlin will allow you to get to know a well-known manufacturer of herbal medicinal products on site.

 
Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)
  

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