Dr Rainer Kolkmann from Diapharm explained the specific requirements for medicines in Europe – from selecting the product category, quality requirements according to GMP and the regulatory requirements for CTD dossiers, to the authorisation and registration processes.
Tasly offered a success story in its presentation about the path to registering its Danshen capsules as a traditional herbal medicinal product (THMP) in Europe.
However, in his welcome speech CCCMHPIE’s vice president, Dr Xu Ming, expressed regret about the fact that only three TCM products of this kind had found their way to Europe as traditional herbal medicinal products, despite the fact that EU directive 2004/24/EG simplifies the registration of traditionally-used herbal medicines. The “Belt & Road Initiative” includes plans to increase the number of TCM products registered as medicines in Europe. CCCMHPIE has been working in China to achieve that aim, with the support of Diapharm, its strategic partner in Europe.
Chinese companies are clearly interested and willing to comply with Europe’s demanding regulations: The symposium attracted 40 participants from 15 different companies. That is because, on the one hand, Europe is a promising market and, on the other, consumers in China consider European sales a sign of quality in products. With its unique knowledge of traditional European and Chinese medicine, Diapharm is helping to build bridges between the two cultures.