The European group, the State Administration of Traditional Chinese Medicine of the People’s Republic of China (SATCM) and the National Key Institute of TCM quality control (NKI-TCM) have teamed up after recognising the need to monitor the quality of TCM sold in Europe, EDQM spokeswoman Fiona Gilchrist told in-Pharmatechnologist.com.
“The European Pharmacopoeia Commission had decided in 2006 to include herbal drugs used in TCM to its work programme with the aim of establishing quality monographs - similar to those already existing in Ph.Eur. for herbal drugs used traditionally in Europe.
“Currently, the programme consists of 100 herbal drugs for which methods for their proper botanical and phytochemical identification, characterisation and control will be elaborated,” Gilchrist continued, added that, to date, 18 monographs have been finalised and a further 30 are under elaboration by the EDQM.
As part of the MoU, SATCM-NKI will contribute to the remaining 50 monographs, conducting experimental work and providing their scientific expertise to the work and deliberations of the European Pharmacopoeia TCM working party.
In Europe, TCMs are usually sold in a raw form to specialised practitioners who prescribe and dispense them to patients in a variety of formats, including in teas and other decoctions.
Precise figures on the quantity of TCM sold in Europe are hard to find although, according to research by the Helmust Kaiser Consultancy, China exports as much as 100,000 tonnes of ingredients each year.
This was a key motivation for the establishing the MoU according to Gilchrist who said: "Since the knowledge of plants imported from China into Europe so far is limited, pharmacopoeial monographs will ensure adequate quality of the material used."
According to Directive 2001/83/EC medicinal products containing TCM herbs or preparations require a Marketing Authorisation by a Competent Authority based on assessment of quality, safety and efficacy.