| 陈一飞,徐瑛,孙搏,李刚.医疗机构开展疫苗早期临床试验的法规要求及关注点探究[J].中国药事,2022,36(1):10-15 |
| 医疗机构开展疫苗早期临床试验的法规要求及关注点探究 |
| Regulatory Requirements and Considerations for Preliminary Clinical Trials of Vaccine in Medical Institutions |
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| DOI：10.16153/j.1002-7777.2022.01.002 |
| 中文关键词: 疫苗 早期临床试验 医疗机构 药物临床试验机构 法规要求 关注点 |
| 英文关键词: vaccine preliminary trial medical institutions GCP institute regulatory requirements regulatory consideration |
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| 中文摘要: |
| 目的：汇总分析疫苗早期临床试验的法规要求及临床试验过程中的关注点，为开展疫苗早期临床试验的医疗机构、相关管理和研究人员提供参考。方法：收集我国现行法规、规范性文件和技术指南， 梳理法规中对疫苗早期临床试验的合规要求。结果与结论：结合医疗机构实际特点，对疫苗早期临床试验中的场地及设施设备、质量管理体系、人员配备、疫苗管理、受试者权益保护等方面的关注重点进行分析讨论，对于做好医疗机构开展疫苗临床试验的能力储备，加速创新疫苗产品的开发，保护受试者权益具有重要意义。 |
| 英文摘要: |
| Objective: To summarize and analyze the regulatory requirements and concerns in early clinical trials of vaccines, and provide references for medical institutions, related management and researchers carrying out early clinical trials of vaccines. Methods: To collect the current regulations, normative documents and technical guidelines in China, and sort out compliance requirements for early vaccine clinical trials in regulations. Results and Conclusion: Based on the practical characteristics of medical institutions, the concerns in facilities, equipment, quality management system, staffing, vaccine management and protection of the rights and interests of the subjects during early vaccine clinical trials were analysied and discussed. It is of great significance to reserve the capacity of medical institutions to carry out vaccine clinical trials, accelerate the development of innovative vaccine products and protect the rights and interests of subjects. |
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