Asian Journal Of Social Pharmacy

Abstract: Objective To review relevant documents on China’s drug conditional marketing authorization system and its implementation, and to provide suggestions for improving the conditional marketing authorization system. Methods The regulations and guiding principles issued by relevant departments were summarized from the implementation of the conditional marketing authorization system in China. The annual drug evaluation report and conditionally approved drug information released by the Center for Drug Evaluation of the National Medical Products Administration from 2020 to 2023 were searched to analyze the problems in the implementation process. Results and Conclusion There were some problems in China’s drug conditional marketing authorization system, such as unclear requirements after listing, individual conditionally approved drugs exceeding the research time limit, and some drug instructions not conforming the specifications. Due to some shortcomings in the implementation process of China’s conditional marketing authorization system, it is recommended that the drug regulatory department improve the research time limit and post market requirements of the drug conditional marketing authorization system as soon as possible, and strengthen the post market supervision of drugs.

Key words: conditional marketing authorization, research time limit, guiding principle