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Since 2015, a series of policies implemented by China's drug review and approval reform have built a good ecological environment for the development of innovative drugs in China. The development of innovative drugs in China has achieved initial results. In recent years, with the increase in the number of pre-approval inspection tasks for innovative drugs, prominent problems such as unclear responsibilities between drug registration applicants and entrusted units, imperfect quality management systems and many GMP observations were found in the pre-approval inspections according to the verification standards such as the "pre-approval inspection procedures" and the "main points and judgment principles on pre-approval inspection". This paper studied the characteristics of the innovative chemical drugs, sorted out the basic situation of the innovative chemical drugs, summarized and analyzed the main problems found in the pre-approval inspection of innovative chemical drugs from 2019 to 2021, and put forward corresponding suggestions, in order to provide reference for the research and development and registration of new drugs in the industry and provide reference for pre-approval inspection of innovative drugs.

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自2015年，药品审评审批改革实施的系列措施为我国创新药的发展构建了良好的生态环境，创新药的研发成果显著。近几年，按照《药品注册核查工作程序》、《核查要点和判定原则》等注册核查规程和标准对创新药研制和生产现场开展注册核查过程中，发现了存在药品注册申请人与受托单位之间的职责不清、质量管理体系不完善、药品生产质量管理规范(GMP)不规范情况突出等问题。本文从化学药创新药注册核查任务的特点进行研究，梳理了化学药创新药注册核查任务的基本情况，通过对2019—2021年化学药创新药注册核查中发现的主要问题进行归纳、总结和分析，提出相应建议，以期为行业创新药研发及注册提供参考，为药品监管注册核查管理工作提供借鉴。

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叶笑，女，主管药师，主要从事药品注册监管与检查研究。E-mail: yex@cfdi.org.cn。

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叶笑，女，主管药师，主要从事药品注册监管与检查研究。E-mail: yex@cfdi.org.cn。

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