Preparation and management of conditional approval drug package inserts in China

ZHAO Ji-yu; TIAN Li-juan

doi:10.20251/j.cnki.1003-3734.2026.13.003

Abstract：Objective:To provide suggestions and references for strengthening the preparation and management of labeling for conditionally approved drugs in China and for enhancing their guiding value for rational clinical drug use.Methods:A comprehensive approach integrating policy and regulation review,current situation and problem analysis,and international experience reference was adopted.We systematically reviewed the relevant policies and regulations on labeling for conditionally approved drugs in China,conducted an in-depth analysis of the core problems existing in the writing specifications,information updates and communiation efficiency of such labeling,and then formulated specific recommendations for improving the management of labeling for conditionally approved drugs in China by drawing on the mature experience of the United States and the European Union systems.Results:Through the above research,we identified the gaps in China's regulatory policy system and in the information update and communication mechanisms for labeling of conditionally approved drugs,as well as international experience that can be used for reference,and proposed systematic solutions covering dedicated technical specifications,update constraint mechanisms,information communication systems and digital regulatory platforms.Conclusion:By improving the preparation and management mechanism of labeling for conditionally approved drugs,we can effectively address the evidence limitations of such drugs,enhance the guiding value of labeling for clinical drug use,provide strong support for ensuring patient medication safety and improving treatment effectiveness,promote the improvement of the lifecycle management level of conditionally approved drugs,and at the same time facilitate the deepening of the reform of China's drug review and approval system and the high-quality development of the pharmaceutical industry.