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Policy diffusion in practice

The case of Brazilian medicinal products regulation

Bibliographic Data

ID21382102
AuthorsLetícia Oyamada Sizukusa (0000-0003-1115-5561, Agência Nacional de Vigilância Sanitária, Brazil; Fundação Getulio Vargas, Brazil), Yuna Fontoura (0000-0003-2908-7448, Fundação Getulio Vargas), Morgana Gertrudes Martins Krieger (0000-0001-8444-6920, Universidade Federal da Bahia)
Year2023
Volume57
Issue3
Publication date2023-01-01
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueRevista de Administração Pública (JOURNAL)
Journal identifiersISSN: 0034-7612 • E-ISSN: 1982-3134
PublisherFapUNIFESP (SciELO) (PUBLISHER)
DOI10.1590/0034-761220220125x
OpenAlexW4384523637
LanguageEN
References cited28

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

Agency (philosophy) · Business · Context (archaeology) · Convergence (economics) · Economic growth · Economics · Geography · Political science · Process (computing) · Relevance (law) · Social science · Sociology · Computer Science · Global Public Health Policies and Epidemiology · Health Systems, Economic Evaluations, Quality of Life · Law · Pharmaceutical Economics and Policy · Public Administration

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