First Traditional Chinese Medicine to be sold in the EU

A Traditional Chinese Herbal Medicine has been licensed for sale in the Netherlands, making it the first TCM drug to receive marketing authorization in a western market. Therefore a press conference was held on Wednesday the 18th of April in the Great Hall of the People in Beijing. NOST China was there to give you report!

The European Directive for herbal medicine requires Traditional Chinese Medicine (TCM) products to undergo a registration process before entering the European market.

Jan van der Greef interviewed by CCTV

SU BioMedicine BV (a spinoff company of TNO) has been successful in registration of the first Chinese medicine in the Netherlands, this has been recognized as a major mile stone for TCM globalization by the Chinese government. The Chinese government has proposed TCM globalization since 1995 and now it is the first time a TCM product has been officially approved marketing authorization by EU member state.

Diao Xin Xue Kang capsules (DXXK) consisting of a dry extract of the root of Dioscorea nipponica Makino (Family of the Yam plants). Originally based on TCM, DXXK was indicated to treat myocardial ischemia. For its registration in EU as traditional herbal medicinal product, DXXK will be used as self-care medication to relieve headaches and muscle pain and muscle spasms in the neck, back and legs. The medicine was developed by the Chengdu Di’ao Pharmaceutical Group and the Chengdu Institute of Biology under the Chinese Academy of Sciences (CAS).

Thanks to its extensive knowledge in the field of systems biology, TNO-SUB has been able to translate Chinese medicine, both diagnosis and treatment into scientific concepts recognized the western scientific community, mandatory for registration in the EU. TNO-SUB will also act as registration holder for DXXK in Europe.

In the preparation of this registration, TNO-SUB has worked closely together with Di’ao to obtain the status of EU-GMP for the whole production line. Di’ao has become for that reason the first Chinese TCM company obtaining EU-GMP certification in the Netherlands.

To celebrate this major achievement a press conference was held in the Great hall of the People. TNO was represented by Tini Hooymans (member of the board of TNO), Jan van der Greef (co-founder of SU Biomedicine and Program director of ‘System Biology’) and Mei Wang (Director of SU Biomedicine). Chinese government was represented among others by Mr. Sang Guowei (Vice-chairman of the standing committee of the national people’s congress), Mr. Chen Zhu (Minister of Health), Mr. Bai Chunli (President of Chinese Academy of Sciences).

During the press conference all major Chinese press (CCTV, Xinhua, People’s daily, etc.) were present. Hereby a short overview.

Tini Hooymans, Mei Wang en Sang GuoWei (Sang Guowei, vice-chairman of the Standing Committee of the National People's Congress) taking a toast

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