List of the most comprehensive CDE accelerated varieties

In 2014, it was reported that the National Drug Evaluation Center (CDE) would actively cooperate with the State Administration to promote the construction of priority evaluation system for generic drugs in clinical need At one time, it was rumored that there would be 62 varieties for priority evaluation At that time, the list of varieties had been preliminarily determined, which would be discussed and implemented internally in advance, and would speed up the evaluation together with innovative drugs It is reported that the common feature of the 62 varieties is that the original research drug patent is about to expire in 2014, there is no domestic drug on the market in China, which is urgently needed in clinical practice, with good safety and effectiveness Moreover, the enterprise has applied for the varieties to the drug evaluation center, and the State Administration is considering the overall accelerated evaluation As of March 12, 2015, Xianda data V3.0 monitored the registration data of CDE accelerated varieties As shown in Table 1, a total of 67 products were approved as accelerated varieties, with a total of 120 acceptance numbers One variety was undertaken in 2010, 19 in 2011, 16 in 2012, 49 in 2013 and 35 in 2014 Of the 67 accelerated varieties, vaccine products accounted for the largest proportion, followed by human coagulation factors At present, the 16 acceptance numbers that are not approved are mainly from the above two categories A total of 47 enterprises are involved in accelerating product registration, including Beijing Tiantan Biological Products Co., Ltd., with 16 acceptance numbers; Sanofi, with 13 acceptance numbers; Wyeth and Bayer are ranked third, with 10 acceptance numbers What kind of products can be accelerated? Of the 120 acceptance numbers, 92 are not marked with reason Of the remaining 28 acceptance numbers with reasons, 50% of the products are the products to be accelerated by the joint meeting, and the visual inspection is the 62 varieties and innovative drugs mentioned above The so-called joint meeting had to mention that in December 2011, the drug review center issued the management specification for the joint meeting of Ministers of drug review center (for Trial Implementation) The joint ministerial meeting is a meeting held to study and solve major problems, difficult problems or common problems in drug technical review, as well as to coordinate and implement relevant resolutions of the director's office meeting of the center or related work of research deployment The participants of the joint ministerial meeting are the convener authorized by the director of the center, the ministers, vice ministers and conference secretaries of all relevant review departments, and other relevant personnel may also be invited to attend the meeting as appropriate The convener of the joint ministerial meeting is responsible for the convening of the meeting, which is usually held once a month What are the 14 acceptance numbers for accelerating variety? They are aripiprazole oral solution, propofol medium / long chain fat emulsion injection, tenofovir fumarate dipivoxil tablets, methoxypolyethylene glycol 2000 polyglycol (53 / 47) two block copolymers, rivaroxaban tablets, procaterol hydrochloride powder spray, irinotecan hydrochloride liposome injection, dextroprofen oral suspension and paclitaxel micelles for injection
There are 19 clinical necessary acceptance numbers, including Hengrui's kapofungin acetate, kapofungin acetate for injection, hao472 and hao472 for injection, aripiprazole oral solution, baixiao'an injection, iodine [125I] sealed seed source, polymyxin e-mesylate sodium, rivaroxaban tablets, sirolimus tablets, polymyxin e-mesylate sodium for injection, lablehai for injection and salt for injection Remifentanil acetate
There are 6 acceptance numbers recommended by the Medical Association, remifentanil hydrochloride for injection of Jiangsu Enhua Pharmaceutical Co., Ltd is recommended by the Chinese narcotics Association, polymyxin e-mesylate sodium and polymyxin e-mesylate sodium for injection of Jiangsu Zhengda Tianqing department are recommended by the infectious diseases branch of the Chinese Medical Association, and the organ transplant branch of the Chinese Medical Association recommends Siro of Wyeth Pharmaceutical Co., Ltd Mousse tablets There are three products related to children's drug use, namely, the right ibuprofen oral suspension of Beijing Hanmei Pharmaceutical Co., Ltd., aripiprazole oral solution of Otsuka Pharmaceutical Co., Ltd and lablehai for injection of Sanofi (China) Investment Co., Ltd.