药品注册申报资料中的研究数据是审评、审批的依据，与申报资料的一致性是注册核查核实的重要内容。对化学药品注册核查发现的原料药/制剂药学研究、原料药/制剂质量综述一致性问题进行总结分析，提示企业申报注意事项，以期为企业减少一致性问题的产生提供参考。

The research data in drug registration applications serve as the basis for evaluation and approval, and the consistency with the application materials is an important aspect of registration verification and validation. This article summarizes and analyzes consistency issues in the pharmaceutical research of active pharmaceutical ingredients (APIs)/formulations and the quality review of APIs/formulations identified during chemical drug registration verification, offering insights for enterprises to avoid notes, thereby providing a reference for reducing the occurrence of consistency issues.

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