Modern European monographs for quality control of Chinese herbs

The actual concern about the safety and efficacy of herbal drugs originating from traditional Chinese medicine (TCM) is based on observations that these medicinal plants may have a high risk potential due to insufficient definitions, problems with identity, purity and falsifications. No uniform legal status for these groups of herbal drugs currently exists in the European Union. For quality control, monographs for TCM herbs can mainly be found in the Pharmacopoeia of the Peoples Republic of China. Based on these facts the Commission of the European Pharmacopoeia decided in 2005 to establish TCM-herbal drug monographs for the most important medicinal plants imported from Far East. These new monographs had to be established and evaluated on the basis of existing monographs in the Chinese Pharmacopoeia (ChP), English edition 2005. Due to important differences in the overall features of EP and ChP, a simple adapt/adopt procedure was not feasible. Therefore, specialist groups were mandated with a corresponding working programme. Some results and actual problems related to this working programme will be presented and discussed.