The main reasons why – despite high demand – only few TCMs are actually available in Europe, are the different regulatory frameworks in China and the EU, Dr Kolkmann said. During his speech he outlined the various registration strategies for TCMs in Europe. Traditional herbal registrations, for example, are considered to be relatively fast and straightforward, but they are only available for herbal ingredients with a long tradition of use. Diao Xin Xue Kang capsules and joint and muscle relief tablets based on Xiangxue, for example, were successfully registered in the Netherlands and in the UK respectively, because their ingredients have been used for at least 15 years in Europe. The active ingredients of Sanchi-tongshu capsules, on the other hand, are yet unknown in Europe. Huasun Group, the Chinese manufacturer of the product, therefore opted for a full application, which will include submitting pre-clinical and clinical trials to the European authorities, with Diapharm as its local service provider in Europe. Diapharm has partnered with the China Chamber of Commerce for Import & Export of Medicines & Health (CCCMHPIE) and its more than 2,400 member companies in order to bring Chinese medicines to Europe.
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