Some new drug approval policies are expected to be issued within this year to speed up the review

In response to the industry's long-standing appeal that the speed of new drug review and approval is too slow, insiders involved in the formulation of new drug approval policies of the drug administration said that the drug administration is currently formulating a series of policies to speed up the review of generic drugs, some of which are expected to be issued in half a year On July 18, the person said at the 2013 China pharmaceutical industry information annual meeting that the biggest trend in the policy is "drug listing value assessment", that is, before applying for drugs, enterprises should first make a value assessment through a third party, including the clinical, social and economic values of drugs If the evaluation system shows that the drug has the above significance, the FDA will accept it "For drugs with a high repetition rate of declaration, such as atorvastatin, the FDA may not accept it." According to the person, other policies being promoted include focusing the review on the consistency research of generic drugs and reference preparations, and focusing on the selection of reference preparations; pre approval certification of pediatric drugs and rare drugs urgently needed by the society, and green channel if they are urgently needed and rare drugs "These programs are under discussion by the drug regulatory bureau Some of them may come out within half a year After they come out, the drug evaluation speed will be much faster." For a long time, the long period of drug approval has troubled the development of China's pharmaceutical industry The heavy workload of review institutions and the small number of approvers are the main reasons In 2012, the State Food and Drug Administration tried to delegate the two rights of new drug technology and drug production technology transfer application to Guangdong food and drug administration "Next, the SFDA is likely to delegate to the provincial SFDA the rights to make up the largest amount of drug applications," the person said.