欧盟与中国药品法律法规及检查体系对比分析

Comparative Analysis of Pharmaceutical Legislation and Inspection System Between EU and China

目的为完善我国的药品监管法律法规及检查体系提供借鉴。方法介绍欧盟药品法律法规和检查体系,对比分析欧盟和我国在药品检查方面的异同。结果与结论欧盟药品监管法律法规体系结构清晰、内容丰富、包容性强、适用性广,欧盟检查体系的建立和运行充分考虑到了各成员国药品行业发展的不平衡性;我国药品监管法律法规及检查体系发展较快,但仍存在不足。欧盟药品检查体系可供我国药品监管改进借鉴。

Objective To provide reference for China’s pharmaceutical legislation and inspection system. Methods By introducing the European Union( EU) drug pharmaceutical legislation and inspection system,the similarities and differences between EU and China in drug inspection were compared and analyzed. Results and Conclusion EU’s pharmaceutical legislation and inspection system are clear in structure,rich in content,good in containment and wide in applicability;its establishment and operation has fully taken into account the imbalance of the development of the pharmaceutical industry in each member country. China’s pharmaceutical legislation and inspection system has developed rapidly,but there are still deficiencies. EU regulatory experience can provide reference for China’s drug regulation.