Are European Pharmacopoeia (Ph. Eur.) monographs on Extracts a useful basis for the development of herbal medicinal products?

The general monograph on Extracts, which classifies extracts into standardised, quantified and other extracts, and the majority of individual extract monographs detailed in the 6^th Edition of the Ph. Eur were elaborated before the Herbal Medicinal Products Committee (HMPC) began publishing Community Monographs on medicinal plants and their extracts. However, the HMPC is now publishing an ever increasing number of Community Monographs, many of which are already the subject of Ph. Eur monographs. As the HMPC Community Monographs are referred to in the quality assessment for the licensing/registration of herbal medicinal products it is important that there are no discrepancies between these monographs and those of the Ph. Eur. However, problems may arise because Community Monographs are based on historical data whereas Ph. Eur monographs are being updated in response to current scientific knowledge and improved analytical methodology.

The appointment of observers by both the HMPC and the Ph. Eur should help in understanding the rationale for the decisions taken by each organisation and lead to harmonisation in the key areas of nomenclature, production and assay methods. This understanding and co-operation should be strengthened by proposals to have meetings between the relevant groups from the two organisations.

The aim of this workshop is to bring together representatives from the Ph. Eur Phytochemistry Groups of Experts, the HMPC Quality Working Group and the pharmaceutical industry to present their views as to both the usefulness and shortcomings of the Eur. Ph. monographs on extracts and to propose resolutions to some of the current problems. These presentations will be followed by a panel and audience discussion to further explore this important area of herbal medicinal product development.