WP7 Kick-off meeting (Phase I) was held on 30th August-1st September 2009 at Brunel University, West London, UK. It was attended by Kelvin Chan, Tai-Ping Fan, Derek Fisher, Svetlana Ignatova, Daryl Rees, Ian Sutherland, Janne Üksti, Yitao Wang, Qihe Xu and Shouming Zhong. The main conclusion from the meeting was that there was an urgent need for a universal regulatory framework for complex herbal mixtures. Without such a framework in place, major research proposals involving both academia and industry cannot be put forward as their commercial impact would be undermined. WP7 members agreed that their priority should be to support the development of harmonised guidelines for the regulation of botanicals. The US guidelines for botanicals have been in place for some time. The Canadians supposedly have a better one and the Australian ones a better one still. The EMEA have been working on a regulatory framework of their own and there were differences of opinion on how far these had progressed. It was agreed that WP7 should set up a small sub-group to bring together an easy-to follow statement on the various regulatory frameworks, emphasising the synergies and highlighting the differences with the aim of helping to establish a universal harmonised regulatory framework for botanicals. In addition to our local expert, Daryl Rees (Salupont Consulting), Dr. Shaw Chen of the FDA and Prof. Gerhard Franz (University Regensburg, Germany; Chairman of the European Working Party of TCM of the European Pharmacopoeia Commission in Strasbourg (France)) have confirmed their willingness to advise us. Because a significant number of WP7 members was unable to attend, a Kick-off Phase 2 meeting will be held in Cambridge during early 2010.

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