Discussion on writing requirements of drug review report
ZHANG Xing-yi
WU Qi-feng
TIAN Na
Abstract：The technical review report of new drug is the core file in the drug approval procedure,it should be conformed to the related laws and meet the guidelines published by the ICH.This article focused on the standard,accuracy and reliability of the review reports.The CDE recruited hundreds of new employees in recent years,the training & normative management of the whole staff and external experts will be followed with interest by the eyes both inside and outside.Based on the experience over fifteen years in technical review,the author of this article shared opinions on how to compose ancredible,elegant report that fit both the standard of government documents and the current laws in the control of human-use medicines.
Keywords：drug reviewtechnical review reportguideline
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2506-2509 )