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The research and development data is the important evidence to prove the safety, effectiveness and quality control of drugs, which also is the important content in pre-approval inspection．New changes have taken place in drug pre-approval inspection after Drug Registration Administration came into force on 1 July 2020. Based on study and analysis of the observations of pre-approval inspection of chemical drugs in the past 2 years, the common problems and changes were put forward. The study provides references for registration applicants and pharmaceutical researchers to improve their quality management.

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药品研发数据是支持药品审评对药品安全性、有效性、质量可控评价的重要证据，是药品注册现场核查的重要内容。2020年7月1日《药品注册管理办法》正式生效后，药品注册核查也发生了新的变化。本文对近2年化学药品药学研制现场核查情况进行梳理，对研制现场核查要点的变化和常见问题进行分析，为新法实施后药品注册申请人加强药品研发管理提供思路。

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胡小娟，女，硕士研究生，工程师，主要从事药品质量管理、药品检查研究。联系电话：(010)68441642，E-mail: hxj2010@126.com。

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胡小娟，女，硕士研究生，工程师，主要从事药品质量管理、药品检查研究。联系电话：(010)68441642，E-mail: hxj2010@126.com。

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