Chinese Herbal Medicine to Enter EU Market

[herbsandhelpers]

Chinese Herbal Medicine to Enter EU Market

A Chinese herbal medicine used for treating myocardial ischemia has been licensed for sale in the Netherlands, making it the first Chinese therapeutic drug to receive marketing authorization in a mainstream western market.

The Dutch Medicines Evaluation Board (MEB) on March 22 granted marketing authorization for Diao Xin Xue Kang capsules, the Chinese Academy of Sciences (CAS) announced at a press conference Wednesday in Beijing.

The medicine was co-developed by the Chengdu Diao Pharmaceutical Group and the Chengdu Institute of Biology under the CAS.

According to mutual recognition arrangements between European Union members regarding medicine registration, the 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.

Bai Chunli, head of the CAS, said the authorization is just the first step for TCM as it enters the international market, urging greater efforts in this regard.

The MEB said in a statement that it granted the authorization for the Diao capsules after a careful evaluation conducted on the basis of "pharmaceutical quality, safety and the justification of traditional use."

"Patients and consumers can now benefit from the clarity provided by registration. They can be sure that for this herbal medicinal product, there has been a careful evaluation of quality, benefits and risks," reads the statement.

Diao Xin Xue Kang capsules were developed in 1988 as the result of an eight-year research project conducted by a team headed by Li Bogang, former head of the Chengdu Institute of Biology and now board chairman of the Diao Group. The capsules have since been extensively used in clinical treatment in China.

Source: XinHua/CriEnglish