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• The expedited approval pathways have broadly expanded worldwide. • Overview of the expedited approval programs in China is provided. • Orphan drug designation should be highly valued in drug development for rare disease/tumor. • A great disparity persists on regulatory frameworks across the world in novel drug development. The use of expedited approval pathways for anticancer drug development, which provide the advantages of high efficiency and cost-effectiveness, has expanded significantly in recent years. During the past decade, a total of 410 new molecular entities have been approved by the US Food and Drug Administration (FDA), with a steady growth of 6.5% in the US. In Europe, 9–75% of approved anticancer drugs were granted at least one expedited approval program. Various expedited pathways have also been implemented worldwide to address underrepresented medical needs rapidly. China has adapted several expedited approval programs, including breakthrough therapy designation, priority review, and conditional approval, to keep up with the growth in pharmaceutical development. It is expected that worldwide standards for drug approval will become more standardized in the next decade. [ABSTRACT FROM AUTHOR]