Development and Assessment of a Decentralization Framework in Iran Pharmaceutical Regulatory Systems Based on Good Governance Indicators.

Background: Decentralization policies are essential for reforming administrative structures and improving service efficiency in government. Proper implementation of these policies promotes effective governance within administrative systems. Objectives: This study proposes a framework for decentralizing regulatory tasks in the pharmaceutical sector to improve good governance indicators. Methods: In the qualitative phase, an Interview Question Guide (IQG) was used to examine the decentralization framework through focused group discussions (FGDs) with relevant experts. The quantitative phase evaluated a sample of domestically produced and imported medicines, collecting perspectives from pharmaceutical companies, Iran Food and Drug Administration (IFDA) employees, and vice-chancelleries of food and drug affairs (VCFDA) staff at universities of medical sciences. The assessed indicators included transparency, rule of law, accountability and responsibility, effectiveness and efficiency, and stakeholder participation. Results: Experts agreed on delegating tasks related to scientific examination and drug procurement policy-making. For supervisory and inspection tasks, deconcentration with VCFDA oversight was recommended. Key suggestions included legislative amendments, strengthening regulatory infrastructure, reforming processes, and learning from past decentralization efforts. In the quantitative phase, 169 companies responded, with over 59% of respondents holding professional doctoral degrees. Among VCFDA respondents, 33 individuals participated, with more than 60% having over ten years of work experience. Transparency scored highest among pharmaceutical companies, while IFDA and VCFDA employees emphasized responsiveness and accountability. Statistical analysis revealed significant differences across all dimensions between IFDA and pharmaceutical company perspectives. Conclusions: Decentralization policies can improve good governance indicators in the pharmaceutical sector if critical requirements are met. Strengthening regulatory infrastructure and clearly defining tasks will enable effective use of governmental and non-governmental capacities.