European Pharmacopoeia: An Optimal Guarantee For The Quality Of Herbals

The European Pharmacopoeia (Ph Eur) lays down mandatory quality and standards for the production and control of medicines in Europe. The standards of the Ph Eur are elaborated, permanently updated and revised by the Group of Experts such as the Phytochemistry Groups 13A and 138 and the TCM Working Party.

Their constant work is the basis for the highest quality standards possible for herbal drugs and herbal drug preparations including those from Traditional Chinese Medicine (TCM). The main targets are the quality and safety of herbal drugs by clear definitions, identifications, purity tests and assay methods. The actual number of monographs on herbal drugs and herbal drug preparations in the 8. Edition of the Ph Eur is a total of 270 including 60 newly elaborated monographs on Chinese Materia Medica (CCMM).

An actual problem in the elaboration of new herbal drug monographs is the establishment and implementation of adequate assay methods. The choice of a typical marker is sometimes difficult and may be discussed in many cases. Mainly when elaborating new TCM monographs, the selection of active or analytical markers is a matter of ongoing discussion, since often no constituents are known which have demonstrated a clear pharmacological or therapeutic activity. Possible alternatives for the classical assay such as semi-quantitative HPTLC methods will be considered.

The chapter of herbal drug preparations, including the different types of the so called standardized, quantified or other extracts will be highlighted as well. Finally, the important role and influence of the 37 Ph Eur Member States and the International Observers for the future development of the herbal drug section in the Ph Eur will be discussed.