In 2004, the EU issued the “EU Directive on Traditional Herbal Medicines”: the
Herbal Medicine/Chinese Medicine which has traditional use evidence (15 years in
the EU and 30 years outside the EU) can exempt clinical registration. Since this policy
issued, EU countries have approved the registration of more than 2000 herbal
medicinal products, about 38% of which are combination products. The first
combination Chinese medicinal product -- Liujunzi Decoction was successfully
registered in Germany in 2018.

 

Kaiwu TCM provides a comprehensive guidance for the registration
of traditional Chinese medicinal products in EU countries, including
scientific research, EU policy and regulations analysis, product
registration and sales etc. By combination of the world's leading
achievements of science and technology with rich experience in
product registration, Kaiwu TCM aims at creating valuable business
opportunities for Chinese medicinal products on overseas markets
such as Europe.)

Milestone

Successful Cases

Technical consulting service for new drug registration of herbal medicine products in China
Clients served: The world's largest herbal medicine  pharmaceutical company Dr. Willmar Schwabe GmbH&Co. KG
(SCHWABE)

2012: Traditional Chinese medicinal product “Diao Xin Xue Kang”was successfully registered in the
European Union (EU) and entered into the EU market as China's first successful case

In Progress

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