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Dental Tribune Asia Pacific Edition No.11, 2017

Dental Tribune Asia Pacific Edition | 11/2017 BUSINESS China accelerates registration process for foreign drugs and medical devices 07 AD BEIJING, China: The Chinese State Council has announced its facilita- tion and expediting of the ap- proval process for overseas phar- maceuticals 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 an- nounced 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 Chi- nese pharmaceutical and medical device registration requirements. “Previously, clinical trial data carried out overseas was not ac- cepted in China. Thus, interna- tional 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,” ex- plained 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 ac- celerated procedure will reduce repetitive trials and thereby sig- nificantly improve efficiency in domestic registration. As a result of the expedited process, approv- als for new treatment will be cut by several years and the latest products and devices will likely be available without delays, benefit- ting medical professionals and pa- tients alike. In addition, prices of pharmaceuticals and medical de- vices 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 advance- ments, the State Council said in a statement. The changes thus ought to boost the domestic phar- maceutical industry by adjusting the industrial structure, encour- aging innovation and making Chi- nese pharmaceutical manufac- turers more competitive. To ensure data accuracy in the new process, the authorities are expected to strengthen su- pervision of foreign clinical tests through efforts such as setting up an overseas clinical trial ex- amination system, among other measures. The fast way to esthetic perfection. The natural fine-structure feldspar veneering ceramic for zirconia frameworks. E 9 1 5 3 VITAVM®9 • Excellent light dynamics and optimum physical properties thanks to the fi ne-structure ceramic • Excellent modeling characteristics for fast and accurate application of the ceramic • Process reliability thanks to long-standing experience www.vita-zahnfabrik.com facebook.com/vita.zahnfabrik VITA – perfect match.

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