CDE drug registration backlog further increased

On March 13, the drug review center of the State Food and Drug Administration (hereinafter referred to as the "drug review center") officially released the 2014 annual drug review report on its website The report shows that by the end of 2014, the total number of tasks to be reviewed by the drug Audit Center has reached 18597, with an increase of 4362 tasks compared with the end of 2013 Judging from the completion of the review tasks of the drug Audit Center, in 2014, the drug Audit Center completed a total of 5261 technical reviews of registration applications, an increase of 12.9% over the completion of the review in 2013 However, due to the 16.5% increase in tasks received by the drug Audit Center in 2014 compared with 2013, the backlog of tasks to be audited by the drug Audit Center has further increased According to the 2014 annual drug review report, the number of new registration applications received by the drug review center in 2014 was 8868 Among them, the chemical drug review task reception increased significantly, nearly 30% higher than the average chemical drug review task reception from 2011 to 2013, accounting for nearly 90% of the total review task reception in 2014, while the reception of traditional Chinese medicine and biological products review task decreased According to the analysis of the annual reports released by the drug audit center over the years, the task volume of chemical drug review and acceptance continued to increase from 2011 to 2014 In 2011, 5884 tasks were received in chemical drug review, 5944 in 2012, 6409 in 2013, and 7829 in 2014 It is understood that the acceptance of chemical drug review task mainly focuses on the confirmatory clinical application, the application of imitation and dosage form modification (anda) and the supplementary application, which account for 87.8% of the total reception While the acceptance of clinical application (ind) and new drug listing application (NDA) was relatively stable, while the acceptance of confirmatory clinical, anda and import re registration increased significantly According to relevant persons of the drug Audit Center, there are a large number of repeated applications for chemical anda and confirmatory clinical applications in 2014 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 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 Among them, more than 100 active ingredients of the same active ingredient variety are: esomeprazole, atorvastatin calcium, clopidogrel bisulfate, entecavir, fasudil, cefdinir, ambroxol and moxifloxacin In addition, 521 TCM registrations were received in 2014, of which 69.3% were supplementary applications Compared with the previous three years, the reception of ind and NDA was relatively stable, while the reception of Anda and supplementary applications decreased 458 applications for registration of biological products, 49.1% of which are supplementary applications In addition to NDA for treatment, the reception of other review tasks decreased compared with 2013 According to the 2014 annual drug review report, the review efficiency has been improved Compared with 2013, in 2014, the number of chemical drugs delivered to the Bureau after review in all categories has increased A total of 4091 registration applications have been reviewed and submitted to the State Administration for approval In addition, 156 registration applications have completed the on-site inspection of the review notice, and 625 registration applications have completed the supplementary information of the review notice enterprise A total of 647 applications for registration of traditional Chinese medicine have been reviewed and submitted to the State Administration for approval Of those with clear review conclusions, 200 are recommended to be approved and 300 are not recommended to be approved The overall rate of disapproval is 52.5% There are 523 registration applications reviewed and submitted to the State Administration for approval, 338 approval conclusions, 111 disapproval conclusions, and the overall disapproval rate is 24.7% The reporter learned that in 2014, the drug audit center took a series of measures to solve the problems of historical and difficult varieties We have carried out the special review work of compound hypertension drugs, compound antibiotics, compound antibiotics and expectorants, varieties with patent problems, varieties related to Article 72 of the measures for the administration of drug registration, varieties with the same review materials, and varieties such as moxifloxacin and daptomycin In the aspect of encouraging drug innovation, we have reformed the application and evaluation method of new drug clinical trials, gradually changing from the original clinical trials mainly approved by stages to one-time clinical trials; improved the working mechanism of submitting pharmaceutical research materials in the form of annual reports during the clinical development of innovative drugs; studied and established the accelerated review of major special varieties of "major new drug creation" Evaluation mechanism At the same time, through the exploration and practice of the pilot work, the drug Audit Center has formulated the review standards for the filing of chemical drug imitations, which lays the foundation for the subsequent implementation of the reform of drug registration and acceptance mechanism Through the pilot work, the paper explores the use of filing review standard as the standard for rapid review of chemical and generic drugs, which provides practical reference for solving the backlog of review tasks of chemical and generic drugs According to relevant sources, at present, the drug audit center is exploring a task management mode combining the length of the review plan cycle to improve the objective and predictability of the review task management Strengthen the management of professional teams at all levels and improve the coordination of review work Increase the input of supplementary application review resources after listing, ensure the timeliness of quality improvement of listed varieties, and ensure public drug use