美国加州药品电子监管制度研究

目的:为完善我国药品电子监管制度提供建议。方法:从监管机构、监管对象、实施流程和监管手段4个方面对美国加利福尼亚州(简称加州)药品电子监管制度进行分析,并从药品打假力度、药品失窃控制能力、缺陷药品召回效率3个方面对其实施绩效进行评价,在此基础上结合我国电子监管现状提出建议。结果与结论:加州的药品电子监管制度以其健全的法律体系、完善的监管流程及强有力的执行力度,在保障药品安全方面获得了良好的社会效益。我国药品电子监管尚处于起步阶段,应借鉴美国经验,进一步加强电子监管立法、成立电子监管工作小组、明确监管重点、延伸监管链条等,充分发挥其安全保障作用。

Study on Drug Electronic Supervision System of California in USA

OBJECTIVE： To provide reference for the improvement of drug electronic supervision system in China. METH- ODS： The drug electronic supervision system of California was analyzed in terms of regulatory agency, object, process, methods. The performance of the system was evaluated in respects of the action of ＂confiscating the fakes＂, quality of drug stealing control and efficiency of defective drug recall. On this basis, suggestions were put forward according to the status quo of drug electronic su- pervision system in China. RESULTS ＆ CONCLUSIONS： The drug electronic supervision system of California is characterized with sound legal system, prefect supervision process and powerful execution, and it created social benefit in the field of drug safe- ty. Drug electronic supervision system of China is still in the starting phase. We should learn successful experience from American to promote this policy by speeding up the legislation, establishing supervision group, emphasizing the object and extending the su- pervisory chain.