| 陈超,刘爱,张景辰.药品上市后变更药学现场检查法规分析[J].中国药事,2023,(12):1381-1385 |
| 药品上市后变更药学现场检查法规分析 |
| Analysis of Inspection Laws and Regulations for Post-marketing Drug Change |
| 投稿时间：2022-05-03 |
| DOI：doi:10.16153/j.1002-7777.2023.12.006 |
| 中文关键词: 药品上市后变更 现场检查 现场核查 药品变更检查 药品监管科学 |
| 英文关键词: post-marketing drug change inspection registration inspection drug change inspection drugregulatory science |
| 基金项目: |
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| 中文摘要: |
| 目的：为了使企业更好地理解我国药品上市后变更相关药学现场检查相关法规要求，使其更好地实施药品上市后变更管理及迎接药品监管部门的现场检查。方法：通过梳理我国境内生产药品上市后变更相关的法律法规、通告公告、通知等，对药品上市后变更相关的检查要求进行了分析。结果：总结了注册和监管2个条线共8类检查类型，并分析了相应的检查启动原则、检查实施单位和检查重点等。结论：通过各类上市后变更现场检查的根本是企业应充分地理解法律法规、指导原则的要求，并依据相关要求做好药品的日常管理工作。 |
| 英文摘要: |
| Objective: To make enterprises better understand the requirements of pharmaceutical inspection lawsand regulations for post-marketing drug change in China, so as to better implement the change management ofpost-marketing drug and meet the inspections of drug regulatory authorities. Methods: The laws and regulations,announcements, notices, etc. related to the post marketing drug changes in China were sorted out, and inspectionrequirements related to post marketing drug changes were analyzed. Results: A total of 8 types of inspectionwere summarized in the two lines of registration and supervision, and the corresponding inspection startingprinciples, implementation regulatory authorities and priorities of these inspections were analyzed. Conclusion:The fundamental reason for inspections of all kinds of post marketing drug changes is that enterprises should fullyunderstand and implement the requirements of laws, regulations and guiding principles in their daily management. |
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