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Regulatory News
 
SFDA to Clear Backlog of Drug Registration Applications
 
5-9-2008

According to SFDA Spokeswoman Yan Jiangying, the State Food and Drug Administration (SFDA) will intensify its efforts to complete the review of all registration applications for class 8 and 9 traditional Chinese medicines and class 5 and 6 pharmaceutical chemicals under the previous drug registration regulations which were accepted by the agency prior to October 1, 2007 when the new Provisions for Drug Registration was put into effect.

Yan said that purpose of this move is twofold - firstly to clear up the backlog of such drug registration applications under review through the use of external evaluation resources, and secondly to eliminate such applications that contain potential major safety hazards, fraudulent practices and "low-level duplications". 

"If the dossiers can not demonstrate the safety, efficacy and quality controllability of drug products under application, they will be rejected", Yan stated.

 
 
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