浅谈药品审评报告的撰写要求

摘要

审评报告是药品技术评价和审批的核心文件,需要在符合法规的框架下,依据国内外技术指导原则加以撰写,其规范性、准确性和可靠性是本文关注的焦点.近年来伴随着CDE的改革举措,新入职人员和外聘专家的培训和规范性管理的重要性日益为业内外所重视.本文结合作者10余年的工作经验,以当前最新的药政法规为审批准绳,以“信达雅”的要求规范文字使用,对审评报告的撰写提出了自己的见解,供业界人士研讨分享.%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.