澳大利亚对境外制药企业GMP认证简介
发布时间：2019-04-19 00:00
【摘要】：目前,国内的医药企业正逐渐登上国际的舞台。为了使国内的药品顺利进入国际市场,药品生产企业首先必须获得当地药监当局的GMP认可。本文简要介绍澳大利亚药监当局如何对海外生产企业进行GMP认证,以期帮助企业进行自身产业布局,统筹安排全球GMP认证策略,简化澳大利亚GMP认证程序,加快开拓国际市场的步伐。同时,也为我国加强国外药品的GMP检查提供参考。
[Abstract]:At present, domestic pharmaceutical enterprises are gradually on the international stage. In order to make the domestic medicine enter the international market smoothly, the drug production enterprise must obtain the GMP approval of the local drug supervision authority first. This paper briefly introduces how Australian drug supervision authorities carry out GMP certification for overseas production enterprises, in order to help enterprises to carry out their own industrial layout, to arrange global GMP certification strategy as a whole, and to simplify Australian GMP certification process. Speed up the pace of opening up international markets. At the same time, it also provides reference for our country to strengthen the GMP inspection of foreign drugs.
【作者单位】： 国家食品药品监督管理总局药品审评中心;
【分类号】：R95
，
本文编号：2460406
[Abstract]:At present, domestic pharmaceutical enterprises are gradually on the international stage. In order to make the domestic medicine enter the international market smoothly, the drug production enterprise must obtain the GMP approval of the local drug supervision authority first. This paper briefly introduces how Australian drug supervision authorities carry out GMP certification for overseas production enterprises, in order to help enterprises to carry out their own industrial layout, to arrange global GMP certification strategy as a whole, and to simplify Australian GMP certification process. Speed up the pace of opening up international markets. At the same time, it also provides reference for our country to strengthen the GMP inspection of foreign drugs.
【作者单位】： 国家食品药品监督管理总局药品审评中心;
【分类号】：R95
，
本文编号：2460406
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