美欧日药品监管趋势对中国药品监管变革的启示

通过检索并分析旧内外一手文献，梳理了上个世纪九十年代以来，美国、欧盟和日本这三个全球最大的医药经济体在药品监管实践中的最新进展和重大变革趋势，结合国内药品监管实践，探讨了中国药品监管变革的路径。作者认为，在全球化时代，国家食品药品监督管理总局应该实施全程化监管，尤其是加强上市后监测，通过提高监管科学以改善决策，提供更好的服务以促进产业发展，并加强国际交流合作，使监管标准与发达国家保持一致，从而促进药品安全。

The impact of drug administration in USA,Europe and Japan on the reform plan in China

It is critical to ensure the safety and efficacy of human drugs through drug administration. Drug administration has a long history in developed countries, such as USA, European Union and Japan, and has achieved great success. In this study, we summarized the important changes in the practice of drug administration in USA, European Union and Japan since 1990s. We also discussed how these changes and experience could be applied in the reform plan in drug administration in China Food and Drug Administration （CFDA）. Our suggestions on future development of CFDA include improving post-market surveillance, advancing regulatory science, strengthening service-oriented regulation, and international cooperation.