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    Home > Medical News > Latest Medical News > A brief analysis of task types and acceptance numbers in CDE new report tasks

    A brief analysis of task types and acceptance numbers in CDE new report tasks

    • Last Update: 2017-04-17
    • Source: Internet
    • Author: User
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    "When searching the registration and acceptance database of smart drugs for drug use, for example, BCTA, the abbreviation marked in the red box in Figure 1, what does it mean?" Recently, we often receive similar feedback from users In view of this situation, I will take you to uncover the true face of these abbreviations Figure 1 the task types in the review of new CDE reports include: ind, NDA, anda, listing application, supplementary application, re registration, etc., which sometimes appear in English Ind, NDA, anda are familiar to all, but the commonly used Chinese ones, such as supplementary application written as the abbreviation SA (figure 2), may be a bit confusing Fig 2 is explained as follows: 1 Ind (investigation new drug): new drug clinical trial application 2 NDA (new drug application): new drug listing application 3 Anda (abbreviated new drug application): brief drug listing application 4 CTA (clinical trial application): clinical trial application 5 BCTA: confirmatory clinical 6 LR (license renew): import re registration 7 SA (supplementary application): supplementary application 8 Biocta: application for clinical trial of biological products for treatment 9 Vaccta: application for clinical trial of biological products for prevention For example, biocta marked in red box in Figure 3 represents application for clinical trial of biological products for treatment Figure 3 and above are partial explanations of acceptance type Figure 4 lists a more comprehensive explanation, hoping to help you In Figure 4, in addition to being confused about the abbreviations of task types, sometimes we are wondering what the English letters in the acceptance number represent? Acceptance number (marked in red box in Figure 5) is the operation mark used by the State Food and drug administration to approve the accepted drug registration application, which is divided into four parts The first part is the basic information of the application, including the first four digits, all of which are indicated by English letters; the second part is the year, which is indicated by the last two digits of the year, the third part is the serial number, and the fourth part is the acceptance form The first part is focused on Figure 5 The first part consists of four digits: the first digit: C represents domestic products, J represents imported products, the second digit: X represents new drugs, Y represents existing national standards (i.e generic drugs), the third digit: H represents chemical drugs, Z represents traditional Chinese medicine, s represents biological products, and f represents auxiliary materials Fourth place: l stands for clinical application, s stands for market application (i.e production), B stands for supplementary application, Z stands for re registration, f stands for sub packaging, and R stands for reexamination examples as follows: cbzr ***** apply for reexamination after the domestic traditional Chinese medicine supplementary application is approved or not cxsl ****** domestic biological products new drug application clinical jyhz ****** imported chemical drug re registration attachment: part of acceptance types and their meanings Note: the third digit marked "a" is "9", for example, cyhb ******: supplementary application for domestic generic drugs; cyhb * * 9 **** supplementary application for domestic generic drugs after bioequivalence Original statement: This article is the original manuscript of yaozhi.com, welcome to reprint, reprint please indicate the source, thank you!
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