藥學研制現場核查主要是對藥學研制情況開展的核查工作。近年來藥品注冊研制現場核查發(fā)現，藥學研制階段存在諸多問題，如真實性、一致性、數據可靠性、技術轉移問題，因此建議藥品研制單位進行規(guī)范性建設，建立與研制行為相匹配的質量管理體系，加強數據可靠性管理，構建完善的技術轉移過程。分析了藥學研制現場核查的問題，提出建議，希望為藥學研制工作規(guī)范化提供參考。

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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