Interpretation of annual report (3): China's innovative drugs will usher in a golden age in 2018

[market analysis of chinapharma.com] on April 2, the State Food and Drug Administration issued the 2017 annual report on food and Drug Administration Statistics (hereinafter referred to as the annual report) Through the data about medicine in the annual report, we can see the basic development status of the medicine industry in 2017, and the author has a series of interpretations on this In the previous article "interpretation of annual report (2): the number of retail single drugstores in China decreased by 8% from 2015 to 2017", the author mainly analyzes the situation of drug licensing in China in 2017 This paper interprets the drug registration in China in 2017   According to the drug registration in the annual report, in 2017, 734 new drug clinical applications were approved in the new drug approval work; 251 generic drug clinical applications and 224 production applications were approved in 2017; 316 imported drug applications and 93 listing applications were approved in 2017; 2158 supplementary drug applications and 546 filing applications were approved by the General Administration in 2017; and direct contact drugs were approved in 2017 There are 552 applications for production of packaging materials and containers, 338 applications for re registration and 62 supplementary applications   The author collected some information of drug registration in 2015 and 2016 by consulting the annual reports: in 2016, 4011 new drug clinical applications were approved in new drug approval; 2949 generic drug clinical applications were approved, 207 production applications were approved; 513 imported drug applications were approved, 28 were listed; 2560 supplementary drug applications were approved, 578 were filed; and the General Administration approved a total of 782 applications for production of packaging materials and containers in direct contact with drugs, 924 applications for re registration and 280 supplementary applications   In 2015, a total of 606 new drug clinical applications were approved; 404 generic clinical applications and 143 production applications were approved; 348 imported drug applications and 36 listing applications were approved; 1623 supplementary drug applications and 871 filing applications were approved by the General Administration; 341 packaging material and container production applications, 349 re registration applications and 5 supplementary import applications were approved by the General Administration; and The Bureau approved 201 domestic supplementary applications Through the comparison of the data of these three years, it is found that from 2015 to 2017, the overall situation of drug registration presents a big ups and downs Among them, the number of clinical approval of new drugs in 2016 was 4011, which decreased nearly six times in 2017; the number of clinical application approval of generic drugs decreased significantly in 2017; the number of supplementary application approval of drugs increased nearly 37% in 2016, but decreased by 18.2% in 2017; the number of production application approval of packaging materials and containers in direct contact with drugs decreased in 2017 The main reason to explore the rise and fall of the data in these three years is the invisible hand of national policy In August 2015, the State Council issued the opinions on the reform of drug and medical device review and approval system, which also means that China has started the reform of drug review and approval system since then The document, which is called "No 44 document" in the industry, specifies five reform goals, including solving the backlog of registration applications It can be seen from the data that the speed of drug approval and review in 2016 has increased significantly, and the number of approvals is really amazing It is understood that for a long time, problems such as slow review and approval of new drugs and overstock of approval have been criticized in China However, under the implementation of the reform of drug review and approval system, the overstock in the past years has been alleviated, and the number of innovative drugs approved has been in a blowout In 2017, drug registration applications become smoother According to the 2017 annual drug review report released by the State Food and Drug Administration on March 23, the time used for the review and approval of all kinds of chemical drug registration applications decreased significantly in 2017, among which the average time used for the first round of review and approval of new drug clinical trials was about 120 working days, 1.09 times of the legal time limit, basically achieving the review and approval within the legal time limit In 2017, a total of 50 drugs with obvious clinical value were accelerated and approved for marketing through the priority review process, including domestic innovative drugs such as recombinant Ebola virus vaccine The clarion call of 2018 has been sounded The industry believes that with the transformation of domestic pharmaceutical enterprises from "generic drug strategy" to "innovative drug strategy", coupled with a series of preferential policies launched by the state, China will usher in the golden age of innovative drugs.