摘要
Abstract
Objective:This study aims to establish a capability maturity assessment model for data management tailored to drug regulatory authorities,aimed at enhancing institutional data governance and improving intelligent drug regulation.Methods:Drawing on standards such as T/CFEII 0013-2023 Guidelines for the Capability Maturity Assessment of Government Data Management,and incorporating the operational the operational and data characteristics of drug regulation,we constructed a maturity assessment model encompassing dimensions including data strategy,governance,architecture,application,security,quality,standards,life cycle.The model includes evaluation indicators and maturity levels,and its scientific validity and practicality were tested through case studies.Results:The model provides drug regulatory authorities with a scientific tool and clear improvement path to advance data management.It facilitates the evolution of regulatory data practices from basic standardization to advanced,value-driven,and data-informed governance,offering a solid foundation for the precision,intelligence,and evidence-based development in drug regulation.关键词
数据管理/能力成熟度评估/药品监管/政务数据治理/实践案例Key words
data management/capability maturity assessment/drug regulation/government data governance/case study分类
药学
