我国临床急需境外已上市药品审评审批制度的优化建议OA

OBJECTIVE To provide references for optimizing the review and approval system of clinically urgent overseas-marketed drugs in China.METHODS The characteristics of the review and approval system for clinically urgent overseas-marketed drugs were analyzed.A comparative research method was employed to examine differences between China and Australia,Switzerland,and Canada in three dimensions:qualification determination for clinical urgency(i.e.,access qualification),review methods,and approval modalities.RESULTS&CONCLUSIONS In China's current system,the legal nature of communication and consultation meetings is ambiguous,as the qualification determination function is embedded within technical consultation procedures without remedy channels.The pre-marketing clinical trial exemption for drugs is disconnected from the post-marketing confirmation obligation,and insufficient access to complete overseas review information weakens risk control effectiveness.A differentiated triage mechanism based on the timing of global approval has not been established,providing insufficient incentives for global simultaneous research and development.International typical regulatory models set access qualification,review methods,and approval modalities as independent modules,forming a quid pro quo relationship by relaxing pre-marketing access conditions and establishing post-marketing conditional approval mechanisms.It is recommended to formulate technical guidelines for the determination of clinically urgent drugs to clarify objective discretionary benchmarks,clarify the legal nature of communication and consultation meetings and allocate remedy channels,mandatorily include clinical trial-exempted varieties in the conditional approval procedure and establish a negative signal linkage mechanism,and implement differentiated triage based on approval timing,so as to improve China's review and approval system.