探索风险量化管理在浦东新区生物医药研发企业特殊药品监管中的应用  

Exploring the Application of Quantitative Risk Management in the Regulation of Special Controlled Drugs for Biopharmaceutical Research and Development Enterprises in Pudong New Area

作　　者：徐颖 沈娴 金剑 隋红 徐雯 张天 韩志云 XU Ying;SHEN Xian;JIN Jian;SUI Hong;XU Wen;ZHANG Tian;HAN Zhi-yun(Shanghai Pudong New Area Market Supervision and Administration)

机构地区：[1]上海市浦东新区市场监督管理局

出　　处：《中国食品药品监管》2023年第8期92-101,共10页China Food & Drug Administration Magazine

摘　　要：特殊药品的监督管理工作是药品监管部门助力研发企业快速发展的重要举措。上海市浦东新区市场监督管理局积极探索特殊药品监管的新机制,有力推动浦东新区生物医药产业的快速安全发展。科研、教学购用特殊药品的许可审批是首次下放到省级以下行政区域,特殊药品较普通药品的法律要求高、监管要求高、责任风险高。通过研究,建立和完善特殊药品的日常监管工作长效机制,该机制是确保特殊药品管得住、不流失和防范购用风险的支撑条件。通过对浦东新区内特殊药品申购企业相关信息的统计,分析并建立风险评估量化体系,在此基础上,形成风险评估量化分值总表和浦东新区特殊药品使用单位风险隐患自查表,并不断完善,充分发挥监管导向作用,指导并督促企业进行自查,及时发现和控制风险,为更有效、有力地实施监管奠定基础,达到对企业的科学监管。The supervision and management of special controlled drugs is an important measure by drug regulatory authorities to promote the rapid development of research and development enterprises.The Shanghai Pudong New Area Market Supervision and Administration actively explores new mechanisms for the regulation of special controlled drugs,effectively promoting the rapid and secure development of the biopharmaceutical industry in the Pudong New Area.It is the first time that the sub-provincial government undertakes the assignment of special controlled drugs approval for scientific and educational purposes.Compared with ordinary drugs,special controlled drugs entail heightened legal and regulatory requirements,along with higher risk responsibilities.Establishing and refining a long-term mechanism for the daily supervision of special controlled drugs is a prerequisite to ensure that these risks can be controlled.Based on the data of research and development enterprises in the Pudong New Area applying to purchase special controlled drugs,a quantitative risk assessment model has been established.On this basis,a“Risk Assessment Quantitative Score Table”and a“Self-inspection Table”have been formed.These models and tables are continuously improved to optimally guide regulatory oversight,instruct and supervise enterprises in conducting self-inspection,and expedite the identification and containment of risks.This approach establishes a foundation for more effective and powerful regulation,ultimately realizing scientific supervision of enterprises.

关 键 词：特殊药品 风险评估 量化管理 

分 类 号：R95[医药卫生—药学]