摘要
本文小结了 1 999年 1 77项新药 (化学药品 )申报品种的专家初步技术审评意见 ;根据化学药品的五种类别 ,对申报资料中存在的问题进行了分析 ;提出了几点建议供新药申报者参考。
The preliminary technical expertise of 177 new drug evaluation data sheet applied for the new drugs (chemical drugs) in 1999 was summarized in this paper. Problems existing in application dossier are analyzed, and the way to deal with the situation are offered based on 5 classes of chemical drugs.
出处
《中国药事》
CAS
2001年第3期169-171,共3页
Chinese Pharmaceutical Affairs
关键词
化学药品
新药申报
新药审评
chemical drugs
new drug application
new drug evaluation
problem
countermeasure
