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Greer Deal, Director of Global Regulatory Services (GRS), has co-authored two key papers on the subject of Chinese Herbal Medicines which were published in the Journal of Ethnopharmacology earlier this year.
These papers were part of one of the key objectives for the consortium, Good Practice in Traditional Chinese Medicine (GP-TCM): to produce a Special Issue for the Journal of Ethnopharmacology focusing on Traditional Chinese Herbal Medicines. All papers are 'open access' and therefore readily available for everyone to read.
Out of these two papers, Greer was most closely involved in the "Future development of global regulations of Chinese herbal products" because of her in-depth knowledge of regulations applicable to herbal products not only in Europe but also elsewhere in the world. From very early on it was clear that this particular paper was going to be quite a challenge because of the very differing regulations throughout the world. It is anticipated that this paper can provide a useful starting point for those considering the export of their herbal products. Although the main focus is Chinese Herbal Medicines, the lessons learnt from the global regulation of Chinese Herbal Medicines will provide valuable insights for regulation of other traditional medicine such as Ayurveda and Unani medicine, as well as other forms of indigenous medicine. It is hoped that this paper will also help to contribute towards the ultimate goal, which is for global harmonisation of the herbal regulations. It was concluded that the World Health Organisation (WHO) is well placed to co-ordinate a consultation process with the aim of putting forward suggestions for harmonisation to key regulatory agencies.
The second paper "Omics and its potential impact on R&D and regulation of complex herbal products" was a fascinating project as the use of 'omics' technology is still very much in its infancy and, as yet, isn't mandatory information for the regulatory bodies. However, they do ask that if 'omics' data is available this should be included in the dossier submission! It was concluded that to predict the future use and importance of 'omics' techniques is difficult but it seems possible that regulatory acceptance of omics techniques and a systems biology approach for the study of Traditional Chinese Medicine (TCM), Chinese Herbal Medicines (CHM) and Chinese Herbal Products (CHP) will not be long delayed. It is expected that current studies and plans employing omics techniques and other integrative approaches will prove to be positive and informative.
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