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目的:通过对中国与欧盟药品质量规制体系的梳理与对比分析,研究我国药品质量规制体系,提出完善建议。方法:借鉴三阶段控制原理,分为事前、事中和事后阶段梳理中国和欧盟的药品质量规制体系,运用对比研究方法,结合规制相关理论,从政策法规、执法机构和执法能力三方面比较其差异。结论:我国的药品质量规制体系相比较欧盟存在一定差距,应该进一步明确相关法律框架,保障执法机构的独立性,保持与公众的信息对称,并提高执法者的综合能力。
OBJECTIVE: Through the combing and comparative analysis of the drug quality regulation system in China and the EU, we study the system of drug quality regulation in our country and put forward some suggestions. Methods: By referring to the principle of three-stage control, the paper divides the quality control system of medicines in China and the EU before, during and after the events. By comparing with the related theories and regulations, comparing the laws, regulations, law enforcement agencies and law enforcement ability difference. Conclusion: There is a certain gap between China’s drug quality regulation system and the EU, and the relevant legal framework should be further clarified to ensure the independence of law enforcement agencies, maintain the information symmetry with the public, and enhance the comprehensive ability of law enforcement officials.