2023/01/01 by Letícia Oyamada Sizukusa, Yuna Fontoura, Morgana G. Martins Krieger · 1 citation
Business, Management and Accounting · Economics, Econometrics and Finance · #Global Public Health Policies and Epidemiology #Health Systems, Economic Evaluations, Quality of Life #Pharmaceutical Economics and Policy
paper · pdf · doi:10.1590/0034-761220220125x
crossref issued 2023/01/01 · crossref published 2023/01/01 · crossref published-online 2023/01/01 · openalex publication_date 2023/01/01 · crossref created 2023/07/17 · crossref deposited 2023/07/17 · openalex created_date 2025/10/10 · crossref indexed 2026/07/27 · openalex updated_date 2026/07/28
Abstract The present study seeks to contribute to a better understanding of policy diffusion processes, more specifically, of the diffusion process from a transnational arena that influenced the regulation of Good Manufacturing Practices (GMP) for medicinal products in Brazil in a context surrounded by international authorities. By conducting qualitative research, we analyzed the process of adhesion of the Brazilian Health Regulatory Agency (Anvisa) to the Pharmaceutical Inspection Co-operation Scheme (PIC/S), initiated in 2010 and achieved in 2021. A process influenced by two constellations of diffusion was identified, motivated by the national agency’s interests in maintaining its relevance and by actors that make up the National Sanitary Surveillance System, in which the PIC/S model of regulatory equivalence and convergence proved to be fundamental for the adaptation of the international reference to the national level, keeping the national system functioning. Such a policy diffusion process became even more relevant in the past years due to the expansion of regulatory convergence and potentially making the various health authorities’ GMP assessment of medicinal products more efficient.