| 摘要: |
| 梳理2016～2020年中兽药注册评审结论为退审的全部品种,查询每个品种退审的具体原因,并进行分类整理。统计涉及各类退审原因的品种及其占全部退审品种百分比和退审具体原因的分布情况,判读各类原因的主次关系。回顾性分析退审原因,探讨其中反映的我国中兽药研发和注册评审方面可能存在的问题,为企业注册提供参考。 |
| 关键词: 中兽药 注册 回顾性分析 退审原因 |
| DOI： |
| 投稿时间：2021-02-02修订日期：2021-05-07 |
| 基金项目:中国兽医药品监察所兽药行业公益性重点专项兽药评审技术规范研究（编号GY202023） |
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| Analysis on Reasons for Disapproval of Traditional Veterinary Drug Registration Application |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| All disapproved products were collected and sorted out in Traditional Veterinary Drug registration application from 2016 to 2020. The different reasons for every disapproved product were classified and analyzed in restropective methods. The proportion that involved the specific reason products in totle disapproved products were calculated and the distribution was reported. Further exploration was made in various disapproved reasons and their primary and secondary relationship. This paper can be reference for Traditional Veterinary Drug registration by means of restropective analyzing the disapproval reasons which reflected in the authorized process. |
| Key words: Traditional Veterinary Drug registration restropective analysis disapproval reason |
