Research on the optimization direction of drug review and approval based on continuous encouragement of innovation
ZHANG Xiao-yong
GAO Li-ping
NIU Jia-wei
LV Xin-huan
CHEN Sheng-xian
ZHANG Xiang-lin
WU Zhi-ang
Abstract：Since the implementation of new drug regulatory policies in 2015,China has achieved remarkable progress in pharmaceutical innovation.With a continuous emphasis on encouraging innovation,it is essential to review and summarize past accomplishments while considering the current development landscape.This will enable the exploration and research of optimizing China's drug evaluation and approval system under the new circumstances,thereby assessing its importance and urgency.The ultimate goal is to further promote the reform and development of a regulatory framework that fosters pharmaceutical innovation.Through literature reviews,comparative researches,questionnaire surveys,brainstorming sessions,and expert discussions,we proposed the overall dimensions and optimization directions for continuously encouraging innovation in drug review and approval management.The analytic hierarchy process(AHP)was employed to analyze the weights of related indicators and determine the ranking of the importance and urgency of these optimization directions.Ours research identified ten key dimensions,including registration classification,acceptance,review procedures,and review timelines.Additionally,35 optimization directions were established,such as refining the definition of new drugs and optimizing the requirements for approval documentation for post-market changes of innovative drugs developed globally in parallel.The study also determined the weight values,importance rankings,and urgency rankings for each optimization direction.The top three in importance are:Refining the definition of new drugs;Optimizing cross-departmental communication and problem-solving mechanisms;Implementing risk-based segmented production management.The top three in urgency are:Optimizing cross-departmental communication and problem-solving mechanisms;Refining the definition of new drugs;Implementing risk-based segmented production management.This study provides a reference for regulatory authorities to continuously optimize and improve the drug evaluation and approval system.
Keywords：innovationdrug review and approval systemanalytic hierarchy process
Publication Date：2025-02-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 256-263 )