Abstract
The consistent request of European patients for a safe access to Chinese Materia Medica (CMM) was the basis, almost 10 years ago, to accept and implement the respective quality monographs for the European Pharmacopoeia (Ph Eur). The safe use of TCM herbal drugs relies on the correct definition of the material in question and further a detailed pharmacognostic botanical and chemical identification. Good agricultural and collection practice (GACP) and all the necessary quality parameters based on Pharmacopoeia standards are an essential prerequisite. However, the existing quality standards of the Chinese Pharmacopoeia (Ch P), even in their English version, could not be directly adopted, due to significant differences between European- and the Chinese Pharmacopoeian legal requirements. Consequently, an experimental re-examination and modification, followed by corresponding validation procedures as well as in some cases, introduction of new analytical methods had to be applied to pre-existing Ch P TCM herbal drug monographs prior to an acceptance by the Ph Eur Commission.
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