Key Takeaways on 2022 China New Drug Clinical Trials Report 

September, 2023 - Yang (Aaron) Gu, Pengfei YOU, Duzhiyun ZHENG, Yuzhen ZHANG, Fengqi YU

On September 7, 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the"NMPA") released "Annual Report on Progress of Clinical Trials for New Drug Registration in China (2022)"(the"2022 Annual Report"). Compared to theDrug Review Annual Reportswith major focus on the drug reviewing process (please refer to Overview of China Drug Review Annual Report (2015 – 2021)), the 2022 Annual Report is to integrate and analyze the data on clinical trials for new drug registration in China (the"NDCT") based on the information from the Drug Clinical Trials Registration and Information Publicity Platform (the"DCTRIP Platform"). In this article, key takeaways from nine (9) aspects of the clinical trials are summarized in order to present the state of the NDCT in China, including: total number of the registered clinical trials, sponsor type, drug type & registration classification, target indications, domestic/multi-regional clinical trials, clinical trial phases, leading sites & participating sites, clinical trials in special populations, initiation & completion time, by which we share our perspective on the development of China NDCT in the future.



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