The National Drug Policy (PNM) in Brazil, approved by Decret GM/MS nº 3.916/1998, has presented a new paradigma of pharmaceutical care, in the area of the Health Sector. From this context, the objective was to analyze the formulation stage of the policy under the federal government regarding the actors (stakeholders) involved in this process. To analyze the results, were integrated the institutional theory to work, the model cycle analysis of public policy, stakeholder theory and concepts related to governance and decision making. Were used qualitative research method, by analyzing the content of formal documents and interviews with actors in society, academia and government. Were identified six decision-making arenas and their stakeholders in the formulation of the PNM, discussing aspects of legitimacy, power and urgency.
policy formulation; policy cycle; health policy; drug policy; stakeholders
