疫苗流通和使用环节生物安全管理现状、问题和监管对策  

Current situation,problems and regulatory measures for biosafety management in the circulation and use of vaccines

作　　者：吴莹 吴浩 周坛树 WU Ying;WU Hao;ZHOU Tanshu(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201210,China)

机构地区：[1]上海药品审评核查中心,上海201210

出　　处：《上海医药》2022年第23期55-58,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：本文采用法规分析和文献调研法,按照疫苗流通和使用环节生物安全管理要求,梳理生物安全管理问题,并提出监管对策,为防控生物安全风险、加强相关监管提供参考。建议企业和使用机构完善疫苗流通和使用环节生物安全体系建设和风险控制,注重电子追溯的管理,确保其生物安全。同时,监管部门应考虑加强相关监管。The problems of biosafety management in the circulation and use of vaccines were sorted out by regulatory analysis and literature research accordance with the requirements of biosafety management in the circulation and use of vaccines,and the regulatory countermeasures were proposed to provide reference for preventing and controlling the biosafety risks in its circulation and use,and its biosafety supervision was also strengthened.It is recommended that enterprises and user institution should improve the construction of biosafety systems and risk control in the circulation and use of vaccines and focus on the management of electronic traceability to ensure its biosafety.The regulatory authorities should strengthen supervision over the distribution and use of vaccines.

关 键 词：疫苗流通和使用 生物安全管理 监管对策 

分 类 号：R979.5[医药卫生—药品] R951[医药卫生—药学]