为支持药品生产技术迭代升级，服务生物医药产业高质量发展，国家药品监督管理局开展优化药品补充申请审评审批程序改革试点工作，统筹国家和省两级监管资源，由省局为化学药品补充申请提供前置立卷、核查、检验等服务，将需要核查检验补充申请的审评时限缩短70%。一般情况下，前置立卷按照补充申请内容进行审查，但若发生影响药品质量的重大变更，则需要进行关联审查。关联审查是产业界和监管界均关心的课题。系统论述补充申请的立题合理性，关联审查的情形、要求，变更研究内容等，为化学药品补充申请的研究和监管提供重要参考。

In order to support the iterative upgrading of drug production technology and serve the high-quality development of the biopharmaceutical industry, the National Medical Products Administration has launched a pilot project to optimize the review and approval procedures for drug supplementary applications. The national and provincial regulatory resources are coordinated, and the provincial bureau provides pre filing, verification, inspection and other services for chemical drug supplementary applications. The review time limit for supplementary applications that require verification and inspection has been shortened by 70%. In general, pre filing is reviewed according to the supplementary application content, but if there are significant changes that affect the quality of the drug, a related review is required. Associated review is a topic of concern for both the industry and regulatory sectors. This article systematically discusses the rationality of supplementary applications, the situation and requirements of associated review, and changes in research content, providing important references for the research and regulation of chemical drug supplementary applications.

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