从“铬超标药用胶囊事件”分析我国药品安全监管

Analysis of Drug Safety Supervision in China from the“Event of Medicinal Capsules with Excessive Level of Chromium”

目的:为完善药品安全监管提供思路与参考。方法:回顾并分析2012年4月的"铬超标药用胶囊事件"产生的原因与药品安全监管中的风险及存在的问题,并提出相应措施。结果与结论:"铬超标药用胶囊事件"产生的原因涉及药品法规有漏洞、药品抽样检验容易规避、企业自检难把关、标准监管乏力、行业自律不力等。目前药品安全监管存在的问题有药品管理法律法规建设滞后,与新时期药品监管形势不相符;食品药品监管体制不稳定,缺乏高效、统一的机制;药品安全尚未形成齐抓共管格局,监管能力建设相对滞后。建议通过建立统一、高效的垂直管理体制以及干预全程、横跨地域的药品合作监管机制,出台《药品安全法》并建立健全适应新形势监管要求的法规体系,强化监管能力建设,从而完善药品安全监管。

OBJECTIVE： To provide reference for the improvement of drug safety supervision. METHODS ： The causes of the ＂event of medicinal capsules with excessive chromium levels＂ （the Event） in Apr. 2012 and the risks and problems of drug safety supervision were analyzed retrospectively, and appropriate measures were proposed. RESULTS ＆ CONCLUSIONS： The causes of the Event include that drug laws and regulations have loopholes; drug sampling is easy to be evaded; the self-test of enterprise is difficult to control ; it is weak for standard supervision; the industry lack of self-regulation. The problems of drug safety supervision contain that the construction of relevant laws and regulations are lagging behind, and do not match with the situation of drug supervision in the new era; food and drug supervision system is instable, while efficient and unified mechanism is absent; a joint pattern of drug safety has not yet formed, and the construction of regulatory capacity is lagging behind. Appropriate measures of the improvement of drug safety supervision involve that unified and efficient vertical management system should be established; interregional drug co-regulatory mechanisms of whole course intervention should be established by seizing; Drug Safety Act should be introduced, and regulatory systems should be established and improved to adapt to regulatory requirements under the new situation; the construction of supervision capacity also should be strengthened.