Policy diffusion in practice: the case of Brazilian medicinal products regulation

Abstract The present study seeks to contribute a better understanding of policy diffusion processes, more specifically, the process from transnational arena that influenced regulation Good Manufacturing Practices (GMP) for medicinal products in Brazil context surrounded by international authorities. By conducting qualitative research, we analyzed adhesion Brazilian Health Regulatory Agency (Anvisa) Pharmaceutical Inspection Co-operation Scheme (PIC/S), initiated 2010 and achieved 2021. A two constellations was identified, motivated national agency’s interests maintaining its relevance actors make up National Sanitary Surveillance System, which PIC/S model regulatory equivalence convergence proved be fundamental adaptation reference level, keeping system functioning. Such became even relevant past years due expansion potentially making various health authorities’ GMP assessment efficient.