CDE: 2014 annual drug review report

    In 2014, 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 I Basic information of drug review in 2014 (I) basic information of the organization drug review center is the drug registration technical review organization of the State Food and drug administration, which is responsible for technical review of drug registration applications 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 (II) acceptance of review tasks: 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 and reception of chemical review tasks are 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 various treatment fields of chemical ind see Figure 4 for the composition of treatment fields applied for Chemical Ind in 2014 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 drugs and generic drugs group of repeated application of active ingredients group of repeated tasks The number of active ingredients involves 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 By the end of 2014, there were 3983 clinical applications for validation of chemicals 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 repeated declaration of validation clinical application of chemical drugs Number of active ingredients: more than 50 applications, 4389 20-29 applications 19 479 40-49 applications 9 401 10-19 applications 64 845 30-39 applications 10 339 10 applications below 569 1530 2 In 2014, 521 applications for TCM registration were received, 69.3% of which were supplementary applications See Figure 5 for details Compared with the previous three years, IND and NDA reception was relatively stable, while ANDA and supplementary application reception decreased 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 (III) completion of review tasks in 2014, the drug review center completed a total of 5261 technical reviews of registration applications, an increase of 12.9% compared with 2013, but the task received increased by 16.5% compared with 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 and classification of drugs proposed to be approved for market in 2014 Subtotal chemicals 128 26 256 68 478 Chinese medicine 110011 biological products 10 2 12 total 501 Table 4 Registration classification of drugs for clinical study approved upon completion of review proposal in 2014 Subtotal of bioequivalence test of clinical trial chemicals 583 159742 Traditional Chinese medicine 28028 biological products 11000 110 880 in total 1 Completion of chemical drug review In 2014, 4091 registration applications for chemical drugs were reviewed and submitted to the General Administration for approval, 156 registration applications for on-site inspection of review notice were completed, and 625 registration applications for supplementary information of review notice enterprises were completed See Table 5 for details Table 5 completion of chemical drug review in 2014 category approval submitted to bureau for approval no approval submitted to bureau for approval other information submitted