【摘要】：目前,國內(nèi)的醫(yī)藥企業(yè)正逐漸登上國際的舞臺(tái)。為了使國內(nèi)的藥品順利進(jìn)入國際市場(chǎng),藥品生產(chǎn)企業(yè)首先必須獲得當(dāng)?shù)厮幈O(jiān)當(dāng)局的GMP認(rèn)可。本文簡要介紹澳大利亞藥監(jiān)當(dāng)局如何對(duì)海外生產(chǎn)企業(yè)進(jìn)行GMP認(rèn)證,以期幫助企業(yè)進(jìn)行自身產(chǎn)業(yè)布局,統(tǒng)籌安排全球GMP認(rèn)證策略,簡化澳大利亞GMP認(rèn)證程序,加快開拓國際市場(chǎng)的步伐。同時(shí),也為我國加強(qiáng)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(píng)中心;
【分類號(hào)】：R95
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本文編號(hào)：2460406