药品数据规范监管的标准化实践

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Standardized Practice of Regulatory Supervision ofDrug Data

GU Xin1.2 CHEN Lei1*LIU Ying1LU Xi1 GULiping1 QUAN Tongzhen³ QIN Shaohua³ （1.Hubei StandardizationandQuality Institution;2.Hubei Optics Valley Standard Innovation TechnologyCo，Ltd.; 3.HubeiMedical ProductsAdministrationIT&ES Centre）

Abstract：Data qualityis the foundationofpharmaceutical supervision.To acelerate thedevelopmentof intelligent pharmaceutical supervision in Hubei province，fivelocal standards were developed in2O24.Theimplementationof these standardscanefectivelyunifydataformats，qualitystandards，andexchangeprotocols.Thestandardsregulatetheentire processofdrugregulatorydataqualitytoensurethequalityandusabilityofdrugdata，whichprovidesstrongsupportfordrug regulatory data quality management in Hubei.

Keywords：standardization;drugdata;data supervision;normalization

0 引言

数据质量是药品监管工作的基础[1]。（剩余4038字）