Evaluating the performance of national authorities has a pivotal role in the development of evidence-based policymaking. Regarding the complexity of the pharmaceutical sector and its severe impacts on public health, Food and Drug Administrations' (FDA) performance should be evaluated at regular intervals. This study aims to depict a comprehensive picture of the Iranian pharmaceutical situation and its structural gaps. In this cross-sectional descriptive study, inspired by indicators proposed by the world health organization (WHO), a checklist was developed with six component topics and 239 indicators. These topics considered the existence and performance of six critical structures, including national drug policy (NDP), regulatory system, medicine supply system, medicine financing, production and trade, and rational use of drugs (RUD). Afterward, the translation validity and then face and content validity of the research tool was confirmed by relevant experts. The data were collected by referring to official documents, reports, and critical informants in the Iranian Food and Drug Administration (IRFDA). According to the WHO indicators, the scores for structures of IRFDA are 80% in NDP, 61.5% in the regulatory system, 64.7% in the medicines supply system, 84.8% in medicines financing, and 60% in production, and trade, and 71.7% in RUD. Considering the status of structures and processes, IRFDA should attempt to provide an action plan commensurate with the NDP. Besides, it should modify the regulations regarding its responsibilities and authorities, develop transparency and accountability in its offices, publish a national essential medicines list, and revise motivational and punitive policies to create RUD
