新药审批办法 meaning in English

provisions for new drug approval
provisions for new drugs approval

Abstract : starting with the examinational procedure and technique specification of new drug license application in china andusa , the differences between two countries in definition of new drug and its classification , clinical study and the new drug license application are compared . development trend of international examinational system and some relevant countermeasures of china are introduced . also , scientific progress of china ' s regulations of application in new drug license to approach the international standard are analyzed
文摘:从中美两国新药审批程序和技术要求入手，对新药的定义、分类、审批程序、新药临床研究申请和新药申请等方面的异同进行了比较和客观评析，介绍了国际新药审评制度发展新动向和我国新药审批办法的若干改革举措，分析了我国新药审批办法与国际接轨的科学化进程