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DOI: 10.1055/s-0031-1282112
Globalisation of TCM Herbal Drugs: Quality Monographs for the European Pharmacopoeia
TCM Herbal Drugs are increasingly used in many countries of the EU. Consequently, there is a great need for herbal drugs with consistent quality as a basis for the required safety of the user. All aspects relevant for the quality parameters have to be achieved in an adequate manner, requiring a broad range of analytical methods to be applied for new herbal drug monographs in the European Pharmacopoeia (EP).
The actual concern about safety and efficacy of the large number of TCM-Herbal Drugs is based upon reports about problems such as botanical identity, purity and current falsifications. In order to respond europe-wide to these problems, new monographs in the framework of the EP have to be established, based upon existing data and monographs of the actual Chinese Pharmacopoeia 2005 Engl. Edition and further the new and updated version of the ChP 2010.
The appropriate selection of TCM-herbal drugs to be elaborated should at least in part reflect the actual situation and impact of TCM in Europe. The inclusion criteria of TCM Monographs were based upon a priority setting of the EP reflecting the volume of use, problems of toxicity, known problems of quality and risk of substitution.
Priority for the elaboration of these new monographs was given for precise definition, identification, test methods and assay procedures, in order to guarantee a reproducible quality.
The actual status of this working programme and the current problems related to different issues of the new TCM monographs for the EP will be reported and discussed.