In one example of fast approval with priority revi

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In one example of fast approval with priority review status, a major MNC submitted its NDA for an investigational drug in early 2017. The drug’s indication was for a serious condition in oncology, and approval was achieved in March 2017, with the drug reaching the market just one month later. 13 Domestic drugs have also benefited from the Priority Review Pathway. It took only ten days to approve a locally developed Ebola vaccine IND in 2017, although the approval was conditional on a commitment to complete a Phase 3 trial later.14 This especially-accelerated process indicates the positive impact of China’s regulatory reforms on drug development, reducing approval timeframes and processes for INDs and NDAs.

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