Diapharm’s Dr Stefan Leyers and Dr Wilfried Dierkes, SUB’s Dr Mei Wang and Huasun’s Dou Kai Cheng, Huang Xiang Ying and Yang Yu discussed Sanchi-tongshu capsules at the BfArM in Germany. (Photo: Huasun Group)
Successful scientific advice for first ‘full application’ TCM in Europe
The Huasun Group (www.huasungrp.com) is one of the leading manufacturers of biopharmaceuticals and TCM products in China. The company considers the active ingredients of Sanchi-tongshu new for the European market, even though they are traditionally used in China. Therefore, it has opted for the so-called full application, which includes submitting pre-clinical and clinical trial data for the product. Diapharm will now attend to the regulatory and clinical steps necessary for Sanchi-tongshu capsules to achieve an EU marketing authorisation.
Internationalisation is an important topic for pharmaceutical companies in China, and manufacturers are looking to expand their international business beyond contract manufacturing. As the EU is one of the most important pharmaceutical markets globally, bringing TCMs to Europe therefore has become a focus area for many Chinese companies.
Europe attractive for manufacturers of Traditional Chinese Medicine
During his visit to the CPHI China 2016, which he attended as a speaker, Diapharm’s general manager Ralf Sibbing discussed this topic with pharmaceutical companies as diverse as Tasly Pharmaceutical Group, Xiuzheng Pharmaceutical Group, Baiyu Group, etc. “There still is an unmet societal need for traditional remedies and for personalized health strategies”, says Ralf Sibbing. For more than 25 years, Diapharm has been working with herbal and traditional herbal medicines, including TCM products, and has helped gain more than 500 marketing approvals for phytopharmaceuticals in Europe already.
In 2014, Diapharm opened a representative office in Shanghai (China), in order to assist Chinese companies as they make their way to Europe. The companies’ services include consulting as well as all day-to-day tasks needed for gaining and maintaining marketing authorisations in accordance with EU law. Diapharm also helps with quality management and performs audits. Over the past years, Diapharm has built a strong cooperation with the China Chamber of Commerce for Import & Export of Medicines & Health Products and has become a point of contact for its 2,400 member companies.
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