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Recently, with the reform of China's regulatory system, a series of accelerated drug development and review processes in China have been gradually introduced (Supplementary Table 1).
From 2016 to 2020, China approved 52 new anti-cancer drugs, of which 38 were developed overseas and 14 were developed within China (Supplementary Table 2).
Figure 1 The characteristics of new anticancer drugs developed through China's special review channel
a.
One of the goals of China's drug regulatory reform is to reduce the lag in drug approvals, that is, to reduce the time lag between new drugs approved by the US FDA but not yet approved by the Chinese market.
Finally, a breakthrough therapy (BT) is planned to be launched in China in July 2020.
Supplementary Table 1 Summary of China's Expedited Plan
advantage
△Displays the priority review requirements in the revised "Drug Registration Regulations" (DRR, effective from July 2020).
* Provision for special audits to shorten the IND audit time from 90 working days to 80 working days, and the NDA audit time from 150 working days to 120 working days.
Supplementary Figure 1 Total development time of new cancer drugs approved in China between 2016 and 2020
(A) Drug review period (b) The total development time is calculated as the time from the date of application of China's investigational new drug (IND) to the first approval.
Supplementary Figure 2 According to China's clinical development strategy, the drug review lag interval for imported new anti-cancer drugs
The drug review lag interval is defined as the interval between FDA approval of a new drug after 2006 and approval in China (between 2010 and 2020).
Supplementary Table 2 List of new cancer drugs approved in China from 2016 to 2020