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| 药物临床研究阶段申办者和生产场地变更研究六：临床研究阶段申办者和生产场地跨境变更的风险分析 |
| Research Ⅵ on the Change of Applicants and Production Sites during the Clinical Research Phase of Drugs: Risk change analysis of cross-border changes of sponsors or production sites in the clinical research stage |
| 投稿时间：2023-12-11 修订日期：2024-04-22 |
| DOI： |
| 中文关键词: 临床研究阶段 申办者 生产场地 跨境变更 风险分析 |
| 英文关键词: clinical research stage applicants production site cross border changes risk analysis. |
| 基金项目: |
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| 中文摘要: |
| 目的:通过对临床研究阶段申办者、生产场地发生跨境变更时的风险变化进行分析,为申办者和生产场地的跨境变更管理提供参考。方法:基于申办者和生产场地不同组合情形的初始风险评价结果和采取风险管控措施后的风险再评价结果,比较分析不同组合情形之间发生变更时变更前后的“风险指数水平”变化。结果与结论:基于初始风险评价结果,有两种变更情形的风险指数水平在变更后较变更前降低；基于风险再评价结果,有四种变更情形的风险指数水平在变更后较变更前降低。 |
| 英文摘要: |
| Objective: To evaluate and analyze the risk changes of cross-border changes in applicants or production sites, and provide reference for the management of cross-border changes in applicants and production sites. Method: Based on the initial risk assessment results of four different combination modes of the applicant and production site, and the risk reassessment results after implementing risk control measures, a comparative analysis is conducted on the changes in the "risk index level" before and after the changes occur between different combination modes. Results and Conclusion: When there are changes between different combination modes, the overall judgment of whether the changes in the "risk index level" before and after the change belong to risk reduction or risk increase is made. The results indicate that the four cross-border change situations belong to risk reduction, providing reference for opening up cross-border changes for applicants and production sites. |
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