Artigo
Regulatory issues on pharmacovigilance in Latin American countries
Registro en:
Pharmaceuticals Policy and Law, v. 16, p. 289-312, 2014.
1389-2827
10.3233/PPL-140390
4160558780902988
0000-0001-8467-7278
Autor
Olivera, María Eugenia
Uema, Sonia Andrea Naeko
Romañuk, Carolina Beatriz
Caffaratti, Mariana
Mastroianni, Patricia de Carvalho [UNESP]
Varallo, Fabiana Rossi [UNESP]
Vazquez, Marta
Fagiolino, Pietro
Maldonado, Cecilia
Vega, Elena María
Galvan, Zully Vera
Maidanag, Mabel
Acostag, Patricia
Rivero, Roxana
Barros, Carolina
Fontana, Daniela
Resumen
Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, Paraguay and Uruguay) were reviewed. Disparities in the legal framework among the countries are observed being those for marketing authorization holders one of the most evident. Theactive rol of the universities and drug information centers for/of pharmacovilance seems to be a positivecommon point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a pointto be developed. Universidad Nacional de Córdoba, Facultad de Ciencias Químicas, Departamento de Farmacia, Argentina Universidad Nacional de Córdoba, Facultad de Ciencias Químicas, Departamento de Farmacia, Unidad de Investigación y Desarrollo, Argentina Universidad Nacional de Córdoba, Facultad de Ciencias Químicas, Centro de Información de Medicamentos, Argentina Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Faculdade de Ciências Farmacêuticas de Araraquara (FCFAR), Departamento de Fármacos e Medicamentos, Rodovia Araraquara/Jaú, km 1, Campus, CEP 14801902, Araraquara, SP, Brasil Universidad de la República, Facultad de Química, Departamento de Ciencias Farmacéuticas, Montevideo, Uruguay Universidad de Chile, Facultad de Ciencias Químicas y Farmacéuticas, Departamento de Ciencias e Tecnología Farmacéuticas, Santiago, Chile Universidad Nacional de Assunción, Facultad de Ciencias Químicas, Assunción, Paraguay Universidad Nacional de Córdoba, Departamento de Farmacoepidemiología e Información Científica, Laboratorio de Hemoderivados, Argentina Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Faculdade de Ciências Farmacêuticas de Araraquara (FCFAR), Departamento de Fármacos e Medicamentos, Rodovia Araraquara/Jaú, km 1, Campus, CEP 14801902, Araraquara, SP, Brasil