中日两国药品GLP法规及检查制度的比较

Comparison of GLP Regulation and Inspection System between China and Japan

目的借鉴其他国家的先进经验,使我国的药品GLP水平能够早日与国际接轨,逐步实现试验数据的国际互认。方法介绍日本药品GLP的实施、法律法规、检查制度和教育培训等情况,与我国进行比较,并对其中可以借鉴的内容进行了总结。结果与结论中日两国在药品GLP法规和检查制度方面有很多相似之处,也各有优势和特点。我们可以借鉴日本在GLP检查方面的有益经验,进一步完善我国的GLP监督检查工作。

Objective To accelerate GLP implementation in China, and reach the mutual recognition of GLP studies by utilizing the experience of developed countries for reference. Methods The situations of GLP implementation, legal basis, inspection system and staff training in Japan were introduced, and compared with those in China, and the conclusions of the useful points were made. Results and Conclusion China and Japan have a lot of similarities in GLP regulation and inspection system, and they also have their own advantages and characteristics. We could draw on the useful experience from Japan to further improve our GLP administration.