Successful scientific advice for first ‘full application’ TCM in Europe
Diapharm, the global service provider and consulting firm for the pharmaceutical industry, is intensifying its business with clients from China.
It recently accompanied Huasun Group Pharmaceutical Factory (China), along with Dr Mei Wang of SU BioMedicine (Netherlands, a TNO company), to the German medicines authority BfArM for a scientific advice meeting on their Sanchi-tongshu capsules. The product is on the way to become the first Traditional Chinese Medicine, or TCM, to be registered via a full application in Europe.
The Huasun Group is one of the leading manufacturers of biopharmaceuticals and TCM products in China. The company considers the active ingredients of Sanchi-tongshu to be new to the European market, even though they are traditionally used in China.
Therefore, it has opted for the so-called full application, which includes submitting preclinical 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 has become a focus area for many Chinese companies.
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 personalised 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) 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 to gain and maintain marketing authorisations in accordance with EU law.
Diapharm also helps with quality management and performs audits. During the past few years, Diapharm has built a strong co-operation with the China Chamber of Commerce for Import & Export of Medicines & Health Products and has become a point of contact for its 2400 member companies.