突发公共卫生事件防控药品应急监管策略探讨

Discussion on Emergency Supervision Strategies for Prevention and Control of Public Health Emergencies

目的加强突发公共卫生事件防控药品应急监管。方法梳理我国药品质量的整体情况,分析应急监管的必要性,借鉴人用药品注册技术要求国际协调会(ICH)的"危害分析和关键控制点("HACCP)理念,分析突发公共卫生事件中防控药品存在的风险和关键控制点,提出针对性建议。结果与结论目前,我国药品质量整体处于较高水平,但假劣药品仍然存在,给公众用药安全和事件防控带来不利影响。同时,因防控需要,对未获得上市许可的疫苗和药品启动的临床试验也可能存在偏离风险,故应加强突发事件防控药品应急监管。建议完善应急法律法规,利用大数据和快检技术提高监管效率,将监督关口前移至出厂前,全面监测并联合惩戒违法广告,及时公开信息以正视听,加强临床试验监管,确保其科学规范及结果准确可靠。

Objective To provide reference for the emergency supervision of the prevention and control drugs in the public health emergencies.Methods The overall situation of China’s drug quality was sorted out,the necessity of emergency supervision was analyzed,the″Hazard Analysis and Critical Control Point″(HACCP)concept of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals of Human Use(ICH)was used to analyze the risks and critical control points of drugs in the prevention and control of public health emergencies,and targeted recommendations were proposed.Results and Conclusion At present,the overall quality of drugs in China is at a high level,but counterfeit and inferior drugs still exist,which adversely affects the public safety and the prevention and control of the public health emergencies.At the same time,due to the need for prevention and control,clinical trials initiated for vaccines and drugs that have not received marketing authorization may also have deviation risks.Therefore,it is necessary to strengthen the emergency supervision of prevention and control drugs for public health emergencies.It is suggested to shift the supervision focus to the manufacturing process,use of big data and fast test technology to combat counterfeit and inferior drugs,jointly punish illegal drug advertisements,strengthen the disclosure of regulatory information and on-site verification of clinical trials.