OBJECTIVES:

Evaluating the performance of national authorities has a pivotal role in the development of evidence-based policy making. Regarding the complexity of pharmaceutical sector and its serious impacts on public health, Food and Drug Administrations’ performance should be evaluated at regular intervals. This study aims to depict a comprehensive picture of Iranian pharmaceutical situation as well as its structural gaps.

METHODS:

In this cross-sectional descriptive study, inspired by indicators proposed by world health organization (WHO), a checklist was developed with six component topics and 239 indicators. These topics consider the existence and performance of six key structures, including national drug policy (NDP), regulatory system, medicines supply system, medicine financing, production and trade, and rational use of drugs (RUD). Afterwards, the translation validity as well as face and content validity of the research tool was confirmed by relevant experts. The data were collected by referring to official documents and reports, as well as key informants in Iranian Food and Drug Administration (IFDA).

RESULTS:

The scores for structures of IFDA according to the WHO indicators are 80% in NDP, 61.5% in regulatory system, 64.7% in medicines supply system, 84.8% in medicines financing, 60% in production and trade, and 71.7% in RUD.

CONCLUSIONS:

Considering the status of structures and processes, IFDA should attempt to provide an action plan commensurate with the NDP, modify the regulations in terms of its responsibilities and authorities, develop transparency and accountability in its offices, publish national essential medicines list, and revise motivational and punitive policies to develop RUD.