CDE issues 2014 annual drug review report

Source: drug review center of the State Food and Drug Administration 2014 annual drug review report on March 13, 2015 drug review center of the State Food and Drug Administration 2014 In, under the leadership of the State Food and drug administration, the drug review center of the State Food and Drug Administration (hereinafter referred to as the drug review center) continued to adhere to the principles of quality, fairness and efficiency, promote reform around improving the construction of the national drug review management system, adhere to the review in accordance with laws and regulations and scientific norms, continuously improve the quality and efficiency of the review, maintain and promote Public health According to the relevant work requirements of the State Food and drug administration, the 2014 annual drug review report is presented to the public 1、 Basic information of drug review in 2014 (I) basic information of organization drug review center is the technical review organization of drug registration of State Food and drug administration, which is responsible for technical review of drug registration application The drug Audit Center has 13 functional departments, 9 of which are technical evaluation departments; the center is staffed with 115 people and 89 technical evaluation personnel There are 48 technical reviewers with senior titles and 31 deputy senior titles, with an average age of 45 years; there are 68 senior reviewers, 65 of whom have the qualification of chief reviewer, with an average review period of 14 years By the end of 2014, the total number of tasks to be reviewed by the drug audit center had reached 18597, an increase of 4362 compared with the end of 2013 （2） In 2014, the drug audit center received 8868 new registration applications (calculated by acceptance number, the same below) See Figure 1 for comparison with the previous year In 2014, the acceptance of chemical drug review tasks increased significantly, nearly 30% higher than that of 2011-2013, accounting for nearly 90% of the total annual review tasks; the acceptance of traditional Chinese medicine and biological products review tasks decreased 1 Reception of chemical review tasks (1) classification of chemical review tasks reception of chemical review tasks is shown in Figure 2 Among them, confirmatory clinical application, imitative and modified dosage form application (anda) and supplementary application accounted for 87.8% of the chemical drug review task Compared with the previous three years, the reception of new drug clinical application (ind) and new drug listing application (NDA) was relatively stable, while the reception of confirmatory clinical, anda and import re registration increased significantly See Figure 3 for details (2) Reception of Chemical Ind in various treatment fields composition of treatment fields applied for Chemical Ind in 2014 is shown in Figure 4 The top five therapeutic fields of domestic ind reception are: anti-tumor drugs, anti infective drugs, digestive system disease drugs, circulatory system disease drugs, endocrine system drugs The top five therapeutic fields of international multi center clinical reception are: anti-tumor drugs, circulating system disease drugs, nervous system disease drugs, digestive system disease drugs, endocrine system drugs (3) Repeated declaration of chemicals there are a large number of repeated declaration of chemicals anda application and confirmatory clinical application By the end of 2014, there were 8713 applications for anda, accounting for 46.9% of the total tasks to be reviewed, involving 1061 active ingredients There are 112 active ingredients (more than 20 tasks of the same active ingredient variety to be reviewed) that have been repeatedly declared seriously, involving 4829 tasks to be reviewed, accounting for 55.4% of the total tasks of Anda Among them, more than 100 active ingredients of the same active ingredient varieties are: esomeprazole, atorvastatin calcium, clopidogrel bisulfate, entecavir, fasudil, cefdinir, ambroxol and moxifloxacin See Table 1 for details Table 1 repeated declaration of chemical and generic drugs number of active ingredients in groups involving tasks number of active ingredients in groups involving tasks number more than 100 applications 8 983 20-29 applications 51 1232 50-99 applications 23 1535 10-19 applications 115 1580 30-49 applications 30 1079 10 applications below 834 2304 as of the end of 2014, there were 3983 chemical and pharmaceutical confirmatory clinical applications to be reviewed, accounting for 21.4% of the total tasks to be reviewed, involving 675 active ingredients There are 42 active ingredients (more than 20 tasks of the same active ingredient variety to be reviewed) that have been repeatedly declared seriously, involving 1608 tasks to be reviewed, accounting for 40.4% of the total tasks of chemical validation clinical to be reviewed Among them, more than 50 active ingredients of the same active ingredient variety are: azilsartan, rofluoristone, ibuprofen (injection), and lulasidone See Table 2 for details Table 2: the number of chemical validation clinical repeated declaration, the number of group active ingredients involved in the number of tasks, the number of group active ingredients involved in the number of tasks more than 50 applications, 4389 20-29 applications, 19479 40-49 applications, 9401 10-19 applications, 64845 30-39 applications, 10339 10 applications and less than 10 applications 569 1530 2 Acceptance of TCM evaluation tasks in 2014, 521 TCM registration applications were received, 69.3% of which were supplementary applications See Figure 5 for details Compared with the previous three years, the reception of ind and NDA is relatively stable, while the reception of Anda and supplementary applications has declined See Figure 6 for details 3 Acceptance of biological products in 2014, 458 applications for registration of biological products were received, of which 49.1% were supplementary applications and 32.5% were therapeutic biological products ind See Figure 7 for details Compared with 2013, in 2014, in addition to NDA for treatment, the acceptance of other review tasks of biological products decreased See Figure 8 for details （3） In 2014, the drug Audit Center completed the technical review of 5261 registration applications, an increase of 12.9% compared with that in 2013, but the task received increased by 16.5% compared with that in 2013, and the backlog of tasks to be reviewed further increased See Figure 9 for the comparison between the tasks received, completed and to be reviewed in 2014 and the previous three years In 2014, see Table 3 and table 4 for the completion of the review by the drug audit center and the approval of the listing and clinical research by the State Administration Table 3 registration classification of drugs proposed to be approved for marketing in 2014 subtotal of new drugs modified dosage form generic drugs imported chemicals 128 26 256 68 478 traditional Chinese medicine 11 000 11 biological products 10 22 12 total 501 Table 4 Registration classification of drugs proposed to be approved for clinical research in 2014 Subtotal of bioequivalence test of clinical trial chemicals 583 159 742 traditional Chinese medicine 28 028 biological products 110 0110 880 1 Completion of chemical review in 2014, 4091 registration applications were submitted to the General Administration for approval, and the registration application for completion of review notice on site inspection 156 625 registration applications for supplementary information of enterprises have been reviewed and notified See Table 5 for details Table 5 completion of chemical drug review in 2014, approval of category, disapproval of other cases, notification of on-site inspection, notification of enterprises, supplementary information, notification of approval, notification of approval, notification of approval, notification of approval, notification of approval, notification of approval, notification of approval, notification of approval, total ind 211 48 27 286-31 confirmatory clinical 356 68 12 436-81 NDA 184 31 16 ※ 231 61 79 Anda 391 180 16 587 10 139 supplementary application 1741 471 199 2411 85 189 import re registration 632 19 84-106 reexamination 14 42 0 56 00 total 2960 842 289 4091 156 625 ※ including 3 completed combination products of medicine and machinery ※ ※ refers to other matters such as withdrawal of enterprise application, transfer of non drug examination center review items to the Bureau, etc Among the registration applications with clear review conclusions, 2960 are recommended to be approved, 842 are not recommended to be approved, and the overall disapproval rate is 22.1% Compared with 2013, in 2014, the number of chemical drugs delivered to the Bureau after review in all categories except review increased See Figure 10 for the comparison between the delivered quantity of each chemical category in 2014 and the previous three years 2 Completion of evaluation of traditional Chinese medicine in 2014, there were 647 registration applications that were reviewed by traditional Chinese medicine and submitted to the General Administration for approval, another 8 registration applications that had been reviewed and notified of on-site inspection, and 100 registration applications that had been reviewed and notified of supplementary information See Table 6 for details Table 6 completion of review of traditional Chinese medicine in 2014, approval of category, disapproval of other conditions, notification to the Bureau, notification of on-site inspection, supplementary information of enterprises, notification to the Bureau, approval of the Bureau, submission to the Bureau, total amount of ind 22 33 10 65-15 NDA 11 7 22 20 6 5 anda 0 31 71 102 0 6 supplementary application 159 205 59 423 2 64 In the total 200 300 147 647 800 registration applications with clear review conclusions, 200 of them are recommended to be approved and 300 of them are not recommended to be approved The overall rate of disapproval is 52.5% See Fig 11 for the comparison between the amount of each category of traditional Chinese medicine delivered in 2014 and the previous three years 3 The completion of biological product evaluation in 2014, 523 registration applications were completed and submitted to the General Administration for approval In addition, 22 registration applications had been reviewed and notified of on-site inspection, and 58 registration applications had been reviewed and notified of supplementary information See Table 7 for details Table 7 review completion of biological products in 2014, approval of category, disapproval of other situations, notification to the Bureau, notification to enterprises on site, supplementary information to the Bureau, approval to the Bureau, submission to the Bureau for examination and approval, total inspection of biological products for prevention ind 29 12 4 45-17 biological products for prevention NDA 27 2 11 1 3 biological products for treatment ind 69 36 27 132-12 supplementary application for NDA of therapeutic biological products 14 5 21 14 2 40 32 285 7 19 import re registration 14 4 22-5 review 0 7 700 total 338 111 74 523 22 58 of the registration applications with clear review conclusions, 338 approved conclusions and no approved conclusions 111 Total disapproval rate was 24.7% See Figure 12 for the comparison between the number of biologicals submitted for review in 2014 and the previous three years 2、 Main work measures and progress in 2014 (1) promote the reform of drug review mechanism, improve the quality and efficiency of review, and do a good job in the formulation of reform plan and basic work of reform According to the unified deployment, we will actively draft and formulate a comprehensive reform plan for the drug review and approval system As the main unit of drug evaluation system reform, it has completed the drafting work of 8 subprogrammes, including technical evaluation management mechanism reform and strengthening technical evaluation capacity building Based on the most prominent contradiction of review task backlog in the current review work, a three-year work plan to eliminate the backlog of review tasks has been developed In order to promote the reform of drug review and approval system, guide social investment and the optimization and upgrading of pharmaceutical industrial structure, the varieties approved for listing and the varieties to be reviewed were collated and compared, and the repeated application for drug registration was sorted out and provided to the General Administration for issuing the catalogue of over repeated drug varieties; the review was well done