【摘要】：目前,國內的醫(yī)藥企業(yè)正逐漸登上國際的舞臺。為了使國內的藥品順利進入國際市場,藥品生產企業(yè)首先必須獲得當?shù)厮幈O(jiān)當局的GMP認可。本文簡要介紹澳大利亞藥監(jiān)當局如何對海外生產企業(yè)進行GMP認證,以期幫助企業(yè)進行自身產業(yè)布局,統(tǒng)籌安排全球GMP認證策略,簡化澳大利亞GMP認證程序,加快開拓國際市場的步伐。同時,也為我國加強國外藥品的GMP檢查提供參考。
[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.
【作者單位】： 國家食品藥品監(jiān)督管理總局藥品審評中心;
【分類號】：R95
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本文編號：2460406