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| The role of the European Pharmacopoeia (Ph Eur)in Quality Control of Traditional Chinese HerbalMedicine in European Member States |
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| DOI：10.15806/j.issn.2311-8571.2014.0021 |
| KeyWord:European Pharmacopeia (Ph Eur), Traditional Chinese Medicine (TCM), TCM monographs, herbal drugs and quality control |
| Author | Institution |
| Mei Wang |
Sino-Dutch Centre for Preventive and Personalised Medicine/SU BioMedicine, Utrechtseweg 48,3700AJ Zeist, the Netherlands |
| Gerhard Franz |
University of Regensburg Department of Pharmacy, Universitätsstraße 31,93040 Regensburg, Germany |
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| Abstract: |
| In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they
can be freely imported in the European Union and other Western European Countries which are signatories of the European Pharmacopoeia
Convention. Consequently, new Ph Eur TCM herbal drug Monographs should be elaborated, based on preexisting Monographs in the Chinese
Pharmacopoeia (ChP) 2010.
Such a program has been inaugurated in 2005 by the Ph Eur Groups of Experts 13 A and B (Phytochemistry). Since then good progress has
been made, elaborating of about one third of the originally proposed 100 TCM herbals being identified as important monographs for the
European Market. Taking into account the many challenges still laying ahead, the establishment of a specialized Working Party (WP) on TCM
with specialists and experts from many EU Member States has been decided by the Ph Eur Commission in 2008 which is highly active ever
since in the examination and elaboration of new TCM herbal drug monographs, primarily to assure the safety of the European patient and
further to provide quality parameters extremely important for all registration and licensing procedures of the respective National Authorities
all over Europe.
This paper is a survey of results and difficulties obtained so far which has been encountered meanwhile in the elaboration process by the Ph
Eur TCM WP of these monographs and will be discussed in detail. Moreover the role of Ph Eur TCM monographs in the European
community is addressed. |
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