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Planta Med 2012; 78(13): 1416-1420
DOI: 10.1055/s-0032-1314939
Regulatory Affairs
Perspectives
Georg Thieme Verlag KG Stuttgart · New York

Current Perspectives on Herb-Drug Interactions in the European Regulatory Landscape

Barbara Steinhoff
1   German Medicines Manufacturersʼ Association (BAH), Bonn, Germany; Co-chair of the ESCOP Scientific Committee
› Author Affiliations
Further Information

Publication History

received 13 January 2012
revised 16 April 2012

accepted 14 May 2012

Publication Date:
06 June 2012 (online)

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Abstract

Herb-drug interactions have turned out not to be a major issue in the European regulatory landscape. For a minority of herbal preparations, herb-drug interactions are clinically relevant, e.g., between high-dose St. Johnʼs wort extracts and a number of chemical substances. The inclusion of adequate information on such interactions into the package leaflet is important for the safe use of the products. Information on potential interactions is also part of the official HMPC monographs. However, only for some herbal preparations described in these monographs, such a potential is known. Thus, in accordance with the relevant European guidance documents, potential interactions should be assessed critically for their clinical relevance, and a balanced assessment is required when regulatory documents are established or regulatory measures are implemented.

Key words

herbal medicinal products - interactions - monographs - pharmacokinetics - regulatory
 

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