2016 drug review report

  In 2016, the State Food and Drug Administration continued to adhere to the principles of quality, fairness and efficiency, adhere to the laws and regulations, scientific and normative review, approved 206 drug production (listing) registration applications (2 traditional Chinese medicine, 188 chemicals, 16 biological products), approved 3666 drug clinical trial registration applications (84 traditional Chinese medicine, 3311 chemicals, 271 biological products) Part In 2016, the State Food and Drug Administration approved the Jinhua Qinggan granules, nanofloxacin malate capsules, betaquiline fumarate tablets, pegylated interferon α 2B injection, tobzumab injection, benalutide injection, 13 valent pneumococcal conjugate vaccine and other important new drugs in the treatment field provide patients with the possibility of obtaining the latest treatment means At the same time, the first domestic generic drugs, such as gefitinib tablets and tenofovir fumarate dipivoxil tablets, were approved, which provided an important guarantee for patients' drug accessibility and affordability The 2016 annual drug review report describes the overall situation of drug registration acceptance, review and approval throughout the year, and analyzes the acceptance, review data and review time limit of chemical drugs, traditional Chinese medicine and biological products 2016 drug review report In 2016, under the strong leadership of the State Food and Drug Administration (hereinafter referred to as the General Administration), the drug review center (hereinafter referred to as the drug review center) closely focused on the relevant requirements of the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), continuously promoted the reform of the review system, and insisted on the review in accordance with laws and regulations and scientific norms, Effectively protect and promote public health Through strengthening the management of review items, refining the review sequence, strengthening the time limit management, establishing a special team, increasing reviewers, authorizing and issuing at different levels, formulating and revising review points, standardizing technical requirements, giving full play to the power of the Provincial Bureau's on duty team, etc., the drug review center has continuously improved the efficiency and quality of review In the whole year, 12068 registration applications (calculated by acceptance number, the same below) were reviewed and submitted to the General Administration for approval, and 3779 new registration applications were received The application for clinical trials of chemical drugs and vaccines, and various registration applications for traditional Chinese medicine and ethnic medicine have basically achieved the review according to time limit, and have completed the phase goals set by GF [2015] No 44 document and the general administration I completion of drug registration application review (I) overall completion of review 1 Completion of review in 2016, the drug review center completed the review and submitted 12068 registration applications to the General Administration for approval, and another 943 registration applications completed the review due to the lack of application information waiting for the applicant to reply to the supplementary information The number of registration applications that have completed the review in the whole year has increased by 26% compared with that in 2015, and the number of registration applications waiting for review has decreased from nearly 22000 at the peak in September 2015 to nearly 8200 (excluding the registration applications that have completed the review and waiting for the applicant to reply to the supplementary information due to the application data defects), basically eliminating the registration backlog See Figure 1 for the comparison of the registration applications completed in 2016 and submitted to the General Administration for approval and waiting in line for review with the previous three years Figure 1 Compared with the previous three years, among the registration applications reviewed and submitted to the General Administration for approval and waiting in line for review in 2016, there were 10060 chemical registration applications, accounting for 83% of the total See Figure 2 for the comparison between the number of drug registration applications completed and submitted to the Bureau in 2016 and the previous three years Figure 2 Comparison between the number of drug registration applications completed and submitted to the Bureau in 2016 and the previous three years In 2016, the center completed 961 new drug clinical trials (ind) application reviews, 3275 confirmatory clinical applications reviews, 690 new drug marketing applications (NDA) reviews and 3655 generic drug applications (anda) reviews The types of registration applications reviewed in 2016 are mainly confirmatory clinical applications, anda and supplementary applications See Figure 3 for the comparison between the number of applications reviewed and submitted to the Bureau in the previous three years Figure 3 Comparison of the number of completed review and submission of various registration applications in 2016 with that in the previous three years 3 According to the opinions on solving the backlog of drug registration applications and implementing the priority review and approval (sfjyhg [2016] No 19, hereinafter referred to as No 19) issued by the State Administration of pharmaceutical industry in 2016, the drug review center has 12 batches of 193 registration applications were included in the priority review process (2 applications for registration of traditional Chinese medicine, 169 applications for registration of chemical drugs and 22 applications for registration of biological products) See Figure 4 for details Among them, there are 85 new drug registration applications with obvious clinical value, accounting for 44% Figure 4 Registration applications included in the priority review procedure note: 1 "Patent expiration" refers to the fourth situation in the priority review and approval scope (I) of Document No 19, i.e "clinical trial application 3 years before the patent expiration and drug production application 1 year before the patent expiration" 2 "Synchronous declaration" refers to the fifth case in the scope of priority review and approval (I) of Document No 19, that is, "the applicant applies for and is approved to carry out clinical trials of new drugs in the United States and the European Union at the same time; the applicant uses the same production line in China and applies for listing in the United States and the European Union drug approval agencies at the same time and has passed the on-site inspection of drug registration application." ”By the end of 2016, 57 of the registration applications included in the priority review process had completed the review, and another 42 registration applications had completed the review, waiting for the applicant to reply to the supplementary information due to the defects in the application information, see Figure 5 for details Figure 5 Review of registration applications included in the priority review process in 2016 Of 57 priority review registration applications that have completed the review, 11 are recommended to be approved for listing (including 2 API registration applications) See Table 1 for details Table 1 list of priority review registration applications that have completed the review and recommended approval for listing note: this table does not include API registration applications (II) completion of chemical drug registration application review 1 Overall situation in 2016, the chemical drug registration applications reviewed by the drug review center and submitted to the General Administration for approval totaled 10060, and another 729 chemical drug registration applications completed the review waiting for the applicant to reply the supplementary information due to the defects in the application materials See Figure 6 for the comparison between the number of chemical registration applications reviewed in 2016 and the previous three years Figure 6 Comparison between the number of chemical drug registration applications completed in 2016 and the number of chemical drug registration applications completed in 2016 compared with the previous three years is shown in Table 2 Table 2 number of chemical drug registration applications completed in 2016 note: 1 "Waiting for supplementary information" refers to the registration application completed in 2016 waiting for the applicant to reply the supplementary information due to the defect of application information; 2 "Withdrawal" refers to the registration application voluntarily applied for withdrawal by the applicant, the registration application returned to the registration department by non central review, the registration application of combination of drugs and devices sent to the device review center and the registration application of raw materials / auxiliary materials withdrawn by related preparations, etc In 2016, the number of Chemical Ind applications, confirmatory clinical trial applications, NDA applications, supplementary applications and import re registration applications reviewed by the drug audit center increased by 37%, 20%, 81%, 67% and 49% respectively compared with 2015 See Figure 7 for the comparison between the number of chemical drug registration applications completed in 2016 and the previous three years Figure 7 Comparison of the number of chemical registration applications completed in 2016 and submitted to the bureau with that in the previous three years 2 In 2016, the drug review center completed the review and submitted 6705 chemical registration applications to the General Administration for approval, including about 87% The registration application of has passed one round of review See Table 3 for the details of each round of review Table 3 review and approval of chemical drug registration applications in 2016 note: 1 "Number of review and approval" refers to the number of registration applications recommended for approval and submitted to the General Administration for approval 2 "Pass of each round of review (%)": one round of review shall be completed if there is no supplementary information for registration application, two rounds of review shall be completed if there is one supplementary information, and three or more rounds of review shall be completed if there are two or more supplementary information This proportion is the percentage of the number of registration applications that have passed the review in this round in the number of such registration applications that have passed the review In 2016, the drug Audit Center completed the review of 23 chemical NDA recommended for listing and submitted to the General Administration for approval In 2016, the drug Audit Center completed the review and recommended approval of 455 Chemical Ind applications for clinical trials, including 316 domestic ind applications and 139 international multi center clinical trial applications (including import ind applications, the same below) See Figure 8 for the distribution of treatment fields Figure 8: distribution of Chemical Ind application treatment areas completed in 2016 and submitted to the Bureau for review and approval of clinical trials Among the ind applications and NDA recommended by the Bureau for approval, it is recommended to approve 2 Applications (1 variety) for the registration of chemical innovative drugs for marketing, and 255 applications (91 varieties, including 42 varieties of anti-tumor drugs) for the registration of chemical innovative drugs for clinical trials See Figure 9 for the distribution of application areas for registration and treatment of innovative chemical drugs that completed the review in 2016 and submitted to the Bureau for approval of clinical trials Figure 9: distribution of application areas for registration and treatment of innovative chemical drugs (in terms of varieties) that completed the review and submitted to the Bureau for approval in 2016 note: 1 The application for registration of chemical innovative drugs refers to the application for registration of chemical drugs of categories 1.1 and 1.2 declared in accordance with Annex 2 of the measures for the administration of drug registration (order 28 of the former State Food and Drug Administration) and the application for registration of chemical drugs of category 1 declared in accordance with Annex 1 of the announcement on the issuance of the work plan for the reform of chemical drug registration and classification (No 51 of 2016) issued by the general administration 2 Due to the application of multiple indications for the same variety, the cumulative number of varieties in each treatment field in the above figure is greater than 91 (3) completion of the review of the application for registration of traditional Chinese medicine 1 Overall situation in 2016, the drug review center completed the review and submitted 1362 applications for registration of traditional Chinese medicine to the General Administration for approval, and another 106 applications for registration of traditional Chinese Medicine completed the review and waited for the applicant to reply and supplement the information due to the defects in the application information See Figure 10 for the comparison between the number of Chinese medicine registration applications completed in 2016 and the previous three years Figure 10 the number of applications for registration of traditional Chinese Medicine completed in 2016 compared with the previous three years is shown in Table 4 Table 4: the number of all kinds of registration applications of traditional Chinese Medicine completed the review in 2016 In 2016, the number of ind applications and NDA applications of traditional Chinese Medicine completed the review by the drug review center increased by 161% and 68% respectively compared with that in 2015 See Figure 11 for the comparison between the number of various registration applications of traditional Chinese Medicine completed in 2016 and the previous three years Figure 11 comparison between the number of various registration applications of traditional Chinese Medicine completed in 2016 and the previous three years note: the above figure is not included in the left over varieties of traditional Chinese medicine in the transitional period 2 Reviewed and approved