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    Home > Active Ingredient News > Drugs Articles > Analysis of the current situation of "CDE three board axe" to speed up the settlement of the backlog of registration review

    Analysis of the current situation of "CDE three board axe" to speed up the settlement of the backlog of registration review

    • Last Update: 2015-09-29
    • Source: Internet
    • Author: User
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    Source: Xianda data 2015-9-29 first board Axe: 71, 72 related items are not allowed to be approved for killing: overlord knife kills thousands of soldiers Description: through the comprehensive database of Xianda data v3.2 registration review, it is found that since June 17, 2015, it is in line with chemical medicine 3.1 The products declared and put on the market in recent three years, whether imported or domestic, are basically more or less auspicious As of September 28, 2015, a total of 280 acceptance numbers are expected to be affected by 71 and 72 articles - "not approved" For the time being, the acceptance numbers of those who died were more than that of those who died were abiolone acetate tablets, agliptin benzoate tablets, aripitan capsules, acitinib tablets and lenalidomide capsules, among which many enterprises were involved Evaluation: reasonable use of policy without review directly returned, how a cool word! The second board Axe: the killing power of centralized review: description of ten million soldiers crowding the only wood bridge: to monitor the change of CDE review sequence in the order of products under centralized review in each department, you can check the change of the order through the CDE review sequence analysis system of Xianda data v3.2, or the products under "centralized review" checked in the comprehensive drug registration and review database There are 706 acceptance numbers of the products in the centralized review list and in the application for production with the serial number obtained In August and September, 185 acceptance numbers are in the approved or accepted status 17 acceptance numbers of cefdinir capsule have been approved or accepted, of which 15 are completed on September 23 There are also 14 acceptance numbers of amlodipine atorvastatin calcium tablets in the above status There are 2 manufacturers with 5 acceptance numbers waiting for on-site production inspection According to the CDE evaluation sequence analysis system of Xianda, you can see that in the Anda sequence, only on September 6, there are more than 800 acceptance numbers for pharmaceutical professional evaluation, which is the rhythm of opening and hanging! Evaluation: enterprises shall not be killed by CDE, or CDE shall be too aggressive to be trampled to death by too many approved manufacturers The third Axe: drag the words to kill: the city gate hangs the exemption card high The varieties previously undertaken by CDE did not enter the sequence immediately, and it would take several days to several weeks to enter the sequence There is no serial number before the queue According to the follow-up analysis of Xianda data v3.2 drug registration and evaluation comprehensive database, there is still no serial number for class 3.1 chemical drugs whose undertaking date is after August 26 (including August 26) Does it take a long time? It is said that in the second half of 2015, CDE's review tasks will reach the turning point of entry and exit, and the number of chemical drugs to be reviewed will be reduced to less than 14000 On the one hand, the National Bureau has seconded staff from Shanghai and Zhejiang provincial bureaus, but since then, it has been found that the quality of the staff seconded by each provincial bureau is not the same, and there is a large shortage of staff; on the other hand, the queue is suspended and the serial number is delayed Comment: this method is true It's just a pure cover up The clinical self inspection and drug administration is still one quarter away from the end of the year If the pending tasks of chemical drugs can be reduced to less than 14000, please wait for the data of Xianda to be broken down.
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