Abstract: Objective To establish an identification model and examples of key performance indicators (KPIs) for drug inspection so as to provide references for formulating drug inspection KPIs by drug inspection institutions. Methods The drug regulatory key performance indicators (KPIs) in the Global Benchmarking Tool (GBT) of the World Health Organization (WHO) were studied, the characteristics of KPIs were summarized, the applications of logical models in the identification and formulation of KPIs were outlined. Results An identification model for drug inspection KPIs was established, eight maintenance modules for identification of drug inspection KPIs were proposed, and examples of drug inspection and inspection ability were developed with the model. Conclusion The identification model for drug inspection KPIs provides the methodology and standards for establishment of KPIs, and promotes the improvement of the quality management system (QMS) for drug inspection.

Key words: Drug Inspection, Drug Quality, Drug Safety, Key Performance Indicators (KPI), Quality Management System (QMS), Global Benchmarking Tool (GBT), Drug Inspection Institution, Inspector