Herbal medicinal products quality guidelines

The first guideline addresses special quality issues of herbal products because of the difference to products containing chemically pure, well-defined active substances. This document should be read in conjunction with Annex 7 Manufacture of Herbal Medicinal Products of Volume 4 of the Rules governing Medicinal Products in the EU. GMP recommendations should be respected and consistent quality can only be assured when... 

Vitamin(s) and mineral(s), which could be ancillary substances in traditional herbal medicinal products for human use, should fulfill the requirements of the "Guideline on summary of requirements for active substances in the quality part of the dossier" (CHMP/QWP/297/97 Rev. 1 corr). 

Differences in criteria and methods of assessment of the characteristics and properties of herbal products may represent a risk for consumers and an obstacle to their free circulation within the Community. Therefore, in 1997, an ad hoc working group was established at the EMEA, which was tasked with addressing the problems of demonstration of quality, safety and efficacy. Subsequently the group became a permanent Working Party of the CPMP and developed a set of guidelines on the requirements and assessment of herbal medicines. 

The first Guidelines for the assessment of herbal medicines were published by the World Health Organization (WHO) in 1991, handing down the basic principles for the analysis of plant preparations (herbal drug preparations, HDPs) and the finished products prepared from these (HMPs) A method for identification and, where possible, quantification of the plant material in the finished product should be defined. If the identification of an active principle is not possible, it should be sufficient to identify a characteristic substance or mixture of substances (e.g., chromatographic fingerprint ) to ensure consistent quality of the preparation. ... 

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