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上世纪90年代起，药品附条件上市审批在美国、欧盟、日本等多国先后实施，成为一种国际上通行的审批方式，国内亦在2017年开始批准药品附条件上市申请。据丁香园insight数据库，2021年至2025年，每年均有20多款，共计超120款药物通过该方式获批。