中日美药品上市后质量评价体系的比较

目的进一步改进和完善＂国家评价抽验＂工作。方法对中日美三国在药品上市后质量评价体系与检测方法的差异进行比较。结果与结论对揭示国产仿制固体制剂与进口原研药内在质量差距提供了思路,从而促进我国药品评价抽样工作更加科学,真正发挥药品评价抽验工作在促进药品生产、检验、监督、完善质量标准等方面的作用。

Comparison of Quality Evaluation System of Post-marketing Drug in China, USA and Japan

Objective In order to further improve and perfect the ＂Random Inspection of Nation-wide Drug Evaluation＂. Methods comparison on the differences in post-marketing quality evaluation system and testing methods among the three countries of China, Japan and the United States is performed. Results and Conclusions This comparison provides ideas to reveal the quality gaps between domestic generic solid preparations and imported original solid dosage forms, so as to promote a more scientific ＂ Random Inspection of Nation-wide Drug Evaluation＂, and bring the effects of the Random Inspection on the manufacturing, inspection, administration and standard revision of drugs into full play.