The complete response letter in FDA's review decision feedback mechanism and its implications for China
LU Jian
SHA Ming-quan
DONG Mei-yi
BAI Yu
Abstract：By sorting out the development history,specific content,institutional advantages,and challenges of the complete response letter system in the U.S.evaluation decision feedback mechanism,as well as the current situation of drug evaluation feedback mechanism in China,suggestions for China's evaluation decision feedback mechanism were put forward.The U.S.complete response letter system has certain institutional advantages in improving the transparency of evaluation and guiding applicants'subsequent research and development,thereby contributing to the advancement of the U.S.pharmaceutical industry.China needs to carry out appropriate transformation in combination with its own regulatory practices and external environment.For innovative drugs and other drugs with clinical application prospects,on the premise of informing applicants of"why it is not feasible",further guidance should be provided on"what to do next";internal evaluation procedures should be optimized to improve the continuity of evaluation;common reasons for rejection of approval should be summarized regularly to provide experience for applicants,avoiding repeated detours;public laws and regulations should be gradually improved to achieve a balance between"disclosure"and"protection".This article provides references for improving the feedback mechanism of drug evaluation and decision-making in China.
Keywords：drug reviewcomplete response letteropenness and transparency
Publication Date：2026-04-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 695-700 )