澳大利亚GMP介绍和对药品生产质量管理的缺陷分析

澳大利亚国家的药品管理机制和中国比较类似,而且对中医治疗和中药产品采取基本认同的态度.近几年,国内一些厂家通过努力,通过了澳大利亚药政当局的现场检查,取得了TGA的GMP证书;这些工作既促进国内医药事业的发展,也加深了中澳之间的交流和合作.笔者通过查阅资料,对澳大利亚药品管理体制,尤其是GMP制度的发展和演化进行了系统分析,希望为相关企业提高借鉴.

Introduction of GMP in Australia and Analysis of Defects in Quality Administration of Medicine Production

The medicine administration system in Australia is some the same of that in China. Moreover, Chinese cure methods and Chinese medicine are approved there in most. Recently, with efforts, some pharmaceutical factories in China have passed on site examinations operated by Australia medicine administration authority, and have obtained TGA and GMP certificates. All of the work mentioned above not only speed up the development of pharmaceutical industry in China, but also extend the intercommunication and cooperation between China and Australia. With respect to the Australia medicine administration system, and by referencing relevant material, the author systematically analyzed the development and evolution of GMP regulation, which can be referenced by enterprises in this field.