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Regulatory reforms have recently led to the introduction of a series of expedited programmes to accelerate drug development and review in China (Supplementary Table 1). These include a priority review (PR) designation to reduce drug review length for drugs that show substantial clinical benefits introduced in 2015, a conditional approval (CA) programme that codified the ability of the National Medical Products Administration (NMPA) to approve drugs intended to treat serious or life-threatening ailments based on surrogate end points or intermediate results in 2017, and accelerated approval for foreign-approved urgently needed overseas drugs (UNODs), based on data mainly generated from trials in other countries in 2018. Anticancer drugs represent the majority of expedited programme-designated drugs so far. Here, we analyse the usage and effects of these programmes on metrics for approved new cancer drugs, such as review length and drug lag compared with the USA (see Supplementary Box 1 for details).
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Nature Reviews Drug Discovery20, 416 (2021)
doi: https://doi.org/10.1038/d41573-021-00080-0
Acknowledgements
The authors gratefully acknowledge Yi-Long Wu (Guangdong Lung Cancer Institute) and Yale Jiang (Tsinghua University) for contributing to this manuscript. We also thank Wei Xie and Yunhe Qin (Pharmcube) for data processing.
