The process of clinical development and regulatory review of new drugs in China has changed substantially owing to regulatory reforms in the past decade. These reforms were designed to encourage the development of innovative products, especially for rare, serious or life-threatening diseases, and to ensure that patients had timely access to these treatments. To assess the effects of these process modifications, we analysed data on investigational new drug (IND) applications and new drug applications (NDAs) for innovative drugs that were approved in China from 2010 to 2020. For details of the dataset and analysis, see Supplementary information.
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Acknowledgements
We thank Yue Yang and Xiaocong Pang for assistance with planning and drafting the manuscript and data analysis.
Competing Interests
The authors declare no competing interests.
