Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain
the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in
Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles
and JavaScript.
Department of Pharmacy, Peking University First Hospital, Beijing, China; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Department of Pharmacy, Peking University First Hospital, Beijing, China; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China; Institute of Clinical Pharmacology, Peking University, Beijing, China.
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.