The backlog of drug evaluation in China has decreased from nearly 22000 to 8200

Source: on March 28, 2017, economic daily encouraged drug R & D innovation, which is the only way for China to move from a big pharmaceutical country to a powerful pharmaceutical country However, the long approval time has seriously restricted the speed of drug innovation Therefore, on the one hand, it is necessary to reform the management mode of clinical trials of drugs and speed up the approval of clinical trials of new drugs; on the other hand, it is necessary to speed up the approval of the listing of drugs urgently needed in clinical practice so as to "untie" the listing of more innovative drugs—— Wu Zhen, deputy director of the State Food and drug administration, said at the recently held national drug registration and management conference: "since the issuance and implementation of the opinions on reforming the review and approval system of pharmaceutical and medical devices for more than one year, the policy environment of China's pharmaceutical industry has improved significantly, the development momentum of the pharmaceutical industry is good, science and technology-based enterprises continue to increase, and pharmaceutical innovation is surging, and innovative drugs The examination and approval of material review is speeding up, and the effect of survival of the fittest is emerging " Specifically, the efficiency of drug registration and evaluation is significantly improved By the end of 2016, the number of drug registration applications to be reviewed has decreased from 22000 at the peak of backlog in 2015 to nearly 8200, and the backlog of registration applications has been effectively alleviated In the 4504 drug registration applications accepted last year, the variety declaration structure was also significantly optimized Take chemicals as an example In 2016, 240 applications for chemical innovative drugs were accepted, an increase of 18% over 2015 Applications for clinical trials of new drugs and applications for listing of new drugs were completed, an increase of 37% and 81% over 2015, respectively At the same time, the time limit for clinical urgent drug review and approval has been greatly shortened, and the public access to drugs has been significantly improved Among them, a batch of innovative drugs and first imitated drugs, such as anti-tumor drug regofinib, anti infective drug ninofloxacin malate capsule, endocrine system drug benaluptide injection, respiratory system disease and anti allergic drug Jinhua Qinggan granules, 13 valent pneumococcal conjugate vaccine for biological products used for prevention, which are used to deal with serious public health problems and major difficult diseases, have passed the priority review and approval Entering the market solved the problem that some patients had no drugs available, and greatly improved the public's sense of access to the reform of drug review and approval system It is worth noting that, after the implementation of the new drug registration classification, the enthusiasm of domestic drug innovation has been significantly improved, and a batch of innovative drugs with the international R & D frontier level have been accepted and declared one after another As of January 31, 330 chemical registration applications have been accepted according to the new classification, including 184 innovative drugs, accounting for 55.76% "Innovation is the eternal theme of the development of the pharmaceutical industry and the only way to move from a pharmaceutical power to a pharmaceutical power Encouraging drug R & D innovation is also the clear direction of the reform of the drug review and approval system." Wu Zhen said that at present, the most prominent problem affecting drug innovation is that the approval time of drug clinical trials is too long, which has a great impact on the opportunities of innovative drugs to seize the market How to change clinical trials? Wu Zhen believes that on the one hand, we should reform the management mode of clinical trials of drugs and speed up the approval of clinical trials of new drugs To study and implement the filing review system for clinical trial application of new drugs, accept the clinical trial data of overseas drugs, gradually realize the international mutual recognition of clinical data at home and abroad, and reduce the R & D cost of enterprises In order to improve the efficiency of ethical review of clinical trials, we should strengthen the ethical review of clinical trials and protect the safety and interests of the subjects On the other hand, it is necessary to speed up the examination and approval of clinical urgently needed drugs, and approve them conditionally For the treatment of diseases that are seriously life-threatening and have no effective treatment means, and for new drugs that have great significance in solving clinical needs, the applicant can apply for relief of clinical trials according to the obtained research data; if the early clinical trial results show preliminary efficacy, if in line with the relevant principles and technical requirements, it can be conditionally approved for listing; support the research and development registration of drugs for rare diseases, and establish To establish a management system for extended sympathetic use of clinical trial drugs In addition, it is necessary to improve the technical support ability and level of review and approval, establish a unified command and dispatch mode of food and Drug Administration Based on risk and review needs, create an atmosphere to encourage innovation, study and formulate a drug test data protection system, and effectively protect the legitimate rights and interests of drug patentees "2017 is a crucial year for deepening the reform of drug review and approval system, and the task of drug registration is unprecedented." Wang Lifeng, director of the pharmaceutical registration department of the State Food and drug administration, said that in view of the current situation of insufficient investment in overall R & D in the industry, lack of R & D talents, weak clinical research capacity, and imperfect ecological environment of drug R & D innovation policies, this year will study and formulate policies and measures to further encourage enterprise R & D innovation, including reform of drug clinical trial management mode, and explore conditions We can encourage the application of drug registration for major and difficult diseases and rare diseases that lack effective treatment At the same time, it will also carry out the registration of drug production process, establish the database of production process, establish the file of drug varieties, establish the drug catalog set, and guide the successful implementation of the consistency evaluation of generic drugs "Generics are the key to solving medical problems, and encouraging the use of generics is a common policy adopted by all countries in the world, including developed countries." Wu Zhen said that this year, we will continue to focus on improving the quality of drugs, strictly control the quality of newly approved generic drugs, manage the increment, do a good job in the consistency evaluation of the quality and efficacy of drugs on the market, improve the quality of stocks, and accelerate the consistency evaluation of generic drugs.