Conformity assessment: 292 be tests have been completed

With the introduction of the policy of "consistency evaluation of quality and efficacy of generic drugs", the attention of clinical trials has been increasing As of September 19, 2018, the platform has obtained 685 generic drug conformity assessment be tests of CTR number, 292 of which have been completed The main pattern of 685 registered be tests for generic drug conformity assessment is as follows: This paper will focus on 292 completed be tests, and make a brief analysis combined with registration and acceptance 01 statistics of the completed be test for conformity assessment the be test for conformity assessment of generic drugs was screened out by comparing the drug listing information and registration information through the statistics of clinical trials from 2016 to 2018 As of September 19, 2018, a total of 292 be tests have been completed The figure below shows the statistics of the number of the completed (terminated) be tests of the generic drug conformity assessment in each month: 02 the most concerned drugs in the completed be tests According to the drug statistics of the be test completed in the consistency evaluation, as of September 19, 2018, metformin hydrochloride tablets had the most be tests completed, reaching 19 registration numbers, followed by amlodipine besylate tablets and Amoxicillin Capsules, 17 of which respectively It can be seen from the registration of generic drug conformity assessment that although there are many be tests of metformin hydrochloride tablets, the acceptance number of conformity assessment is only 5, which has not yet passed The list of the varieties that have completed the be test is as follows: 03 the total number of be tests completed by each enterprise, as of September 19, 2018, a total of 154 enterprises have completed the be test of generic drug conformity evaluation, and only one of 91 enterprises has completed the be test Qilu Pharmaceutical Co., Ltd has completed the largest number of be tests with 12 registration numbers, followed by Sichuan Kelun with 10 registration numbers Top 10 enterprises are almost large domestic pharmaceutical enterprises It can be seen that large pharmaceutical enterprises pay more attention to the consistency evaluation of quality and efficacy of generic drugs, and show strong strength 04 according to the data of 289 catalogue in the completed be test, as of September 19, 2018, 176 clinical trials belonging to 289 catalogue in the registration number of the completed conformity assessment be test, accounting for 60.27% of the total A brief list of the most popular drugs that have completed the be test in the consistency evaluation of the 289 catalog is given It can be seen that they are basically the same as the varieties that have completed the be test as a whole That is to say, the drugs that have completed the most be tests currently belong to the 289 catalog 0569 drugs may enter the declaration According to the drugs and enterprises that have been accepted in the current consistency evaluation, 142 drugs corresponding to the completed be test have not yet been declared; after weight removal, 69 drugs from 91 enterprises can be found (according to the name of the enterprise and the name of the drug respectively); the following table is the number of enterprises corresponding to the varieties that have completed the be test but have not been accepted In general, at present, the number of be test registration related to consistency evaluation is steadily increasing, and about 20 tests are terminated every month, and some of them are accepted normally The data of this paper come from the "Chinese clinical trial database" and "drug registration and acceptance database" of Yaozhi