Dental News - China accelerates registration process for foreign drugs and medical devices

Dental Tribune International

Thu. 2. November 2017

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BEIJING, China: The Chinese State Council has announced its facilitation and expediting of the approval process for overseas pharmaceuticals and medical device manufacturers seeking to enter the Chinese market. The measures are part of efforts to lower research and development costs and reduce delays for new medical products entering the domestic market.

As reported by the Global Times, one of the changes announced in October is that foreign clinical trial data obtained from overseas centres can now be used in registration applications—as long as the trials comply with Chinese pharmaceutical and medical device registration requirements.

“Previously, clinical trial data carried out overseas was not accepted in China. Thus, international drug makers had to repeat the trials if they wanted to bring new drugs and medical devices into the Chinese market, which could take several years,” explained Yingtao Wang, head of the Beijing representative office for Germany-based dental material manufacturer DMG.

According to Lifeng Wang, a representative of the China Food and Drug Administration, the accelerated procedure will reduce repetitive trials and thereby significantly improve efficiency in domestic registration. As a result of the expedited process, approvals for new treatment will be cut by several years and the latest products and devices will likely be available without delays, benefitting medical professionals and patients alike. In addition, prices of pharmaceuticals and medical devices from overseas are expected to fall.

The current market approval procedure has been insufficient in supporting scientific innovation, resulting in the Chinese market lagging behind global advancements, the State Council said in a statement. The changes thus ought to boost the domestic pharmaceutical industry by adjusting the industrial structure, encouraging innovation and making Chinese pharmaceutical manufacturers more competitive.

To ensure data accuracy in the new process, the authorities are expected to strengthen supervision of foreign clinical tests through efforts such as setting up an overseas clinical trial examination system, among other measures.

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