EMA Guideline on Quality of Herbal Medicinal Products Updated

The finale version of the revised EMA guideline on quality of herbal medicinal products/ traditional herbal medicinal products (EMA/CPMP/QWP/2819/00 Rev.2) was published at the end of September 2011. This guideline replaces the previous one from March 2006.

The update of the document has been necessary to incorporate new definitions and responsibilities which have been developed since that time. Moreover, further clarifications and corrections have been added.

The guideline describes the differences between medicinal products containing chemically defined APIs and herbal medicinal products and the resulting requirements and problems. It applies to both human and veterinary medicinal products.

The guideline should be read in conjunction with Annex 7 on herbal products of the EU GMP and the GACP Guideline from 2005.

The following topics are addressed:

  • Qualitative and quantitative particulars of APIs for herbal medicinal products
  • Description of the preparation of herbal medicinal products
  • Control of starting materials
  • Intermediate control during the manufacturing process
  • Control of the finished product
  • Stability tests

At the end of the guideline, you can find a detailed glossary with definitions.

For further information please see the complete "Guideline on quality of herbal medicinal products1/traditional herbal medicinal products".

Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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