Pharmacopoeia Monographs for Chinese Herbal Drugs for Quality Assurance

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.

In a first period, a working program, existing of 75 monographs was established by the Commission of the Ph Eur, out of which almost 50 new TCM herbal drug monographs have been implemented for the Ph Eur so far. Often occuring problems and new results of this work period will be provided and discussed in detail.

A specific problem will be the further highlighted, the equivalence of commercial TCM granules with the corresponding herbal drug and the respective aqueous extracts i.e. decoctions. It was found that in many cases the so-called phytoequivalence between commercial granules and genuine herbal drugs is questionable.

Finally, it will be highlighted that for the future a closer collaboration between Europe and China i.e. between the Ch P and the Ph Eur is still an essential prerequisite for a successful, and for the patient a safe utilization of CMM in Europe.