First Chinese herbal drug to enter EU market
A Chinese herbal medicine used for treating a heart disease has been licensed for sale in the Netherlands, making it the first Chinese therapeutic drug to receive marketing authorization in a western market.
Beijing: A Chinese herbal medicine used for treating a heart disease has been licensed for sale in the Netherlands, making it the first Chinese therapeutic drug to receive marketing authorization in a western market.
The Dutch Medicines Evaluation Board (MEB) March 22 granted marketing authorization for Diao Xin Xue Kang capsules, the Chinese Academy of Sciences (CAS) said here Wednesday.
The medicine, used for treating myocardial ischemia, was co-developed by the Chengdu Diao Pharmaceutical Group and the Chengdu Institute of Biology under the CAS, Xinhua reported Wednesday.
Myocardial ischaemia, is a disease characterized by reduced blood supply of the heart muscle, usually due to coronary artery disease. Its risk increases with age, smoking, diabetes, and high blood pressure.
According to European Union rules, a medicinal product needs to undergo routine application procedures to expand its authorization scope to other EU nations.
Although traditional Chinese medicine (TCM) products are already sold in major international markets, they are marketed solely as dietary supplements or non-medicinal treatments, as opposed to being marketed as therapeutic drugs.
The European Medicines Agency (EMA) in 2011 required TCM products to undergo a registration process before entering the European market, making it more difficult for TCM to penetrate the western medicine market.
Zhang Boli, president of the China Academy of Chinese Medical Sciences, expressed hope that the move will fuel the international marketing of TCM.
Diao Xin Xue Kang capsules were developed in 1988 as the result of an eight-year research project. The capsules have since been extensively used in clinical treatment in China.