从药品技术审评的角度看GLP实施的必要性  

The Necessity of GLP Implementation From Point View of Drug Technical Evaluation

作　　者：岑小波[1] 赵瀛兰[1] 王莉[1] 朱家谷[2] 韩玲[2] 

机构地区：[1]四川大学华西医院国家成都中药安全性评价中心,610041 [2]国家食品药品监督管理局药品审评中心

出　　处：《中国药事》2005年第7期390-392,共3页Chinese Pharmaceutical Affairs

摘　　要：临床前安全性研究的不规范性会影响药品的科学评价。GLP有利于增进药品技术审评的科学化与规范化,而药品技术审评有助于促进GLP的实施与完善。二者应协调发展、与时俱进,相得益彰,提高我国的新药研发水平,促进医药产业的发展,保障人民健康。Absence of standardization in pre-clinical safety study will influence the scientific evaluation of drugs, while implementation of GLP will facilitate scientific and standardized technical evaluation of drugs. On the other hand, drug technical evaluation will, also promote the implementation and improvement of GLP. We should develop these two in phase and continuously so as to bring out the best in each other, and thus improve level of drug research, advance development of pharmaceutical industry, and guarantee the safety and efficacy of drugs.

关 键 词：GLP 药品技术审评 

分 类 号：R954.7[医药卫生—药学]