药学研制现场核查主要是对药学研制情况开展的核查工作。近年来药品注册研制现场核查发现，药学研制阶段存在诸多问题，如真实性、一致性、数据可靠性、技术转移问题，因此建议药品研制单位进行规范性建设，建立与研制行为相匹配的质量管理体系，加强数据可靠性管理，构建完善的技术转移过程。分析了药学研制现场核查的问题，提出建议，希望为药学研制工作规范化提供参考。

The on-site verification of pharmaceutical research mainly verifies the status of pharmaceutical research work. In recent years, on-site inspections of drug registration and development have found that there are many problems with authenticity, consistency, data reliability, and technology transfer in the pharmaceutical development stage. Therefore, it is recommended that drug development enterprises carry out standardized construction, establish a quality management system that matches their research and development behavior, strengthen data reliability management, and build a sound technology transfer process. This article analyzes the problems of on-site verification in pharmaceutical development and proposes suggestions, hoping to provide reference for the standardization of pharmaceutical development work.

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