Regulatory issues on pharmacovigilance in Latin American countries

Article type: Research Article

Authors: Olivera, María Eugenia^; | Uema, Sonia Andrea Naeko^; | Romañuk, Carolina Beatriz^; | Caffaratti, Mariana | Mastroianni, Patricia Carvalho | Varallo, Fabiana Rossi | Vazquez, Marta | Fagiolino, Pietro | Maldonado, Cecilia | Vega, Elena María | Galvan, Zully Vera | Maidanag, Mabel | Acostag, Patricia | Rivero, Roxana | Barros, Carolina | Fontana, Daniela

Affiliations: Departamento de Farmacia, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Argentina | Unidad de Investigación y Desarrollo en Tecnología Farmacéutica, CONICET and Departamento de Farmacia, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Argentina | Centro de Información de Medicamentos, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Argentina | Departamento de Fármacos e Medicamentos, Faculdade de Ciências Farmacêuticas, Universidade Estadual Paulista Júlio de Mesquita Filho (FcFAR/UNESP), São Paulo, Brazil | Departamento de Ciencias Farmacéuticas, Facultad de Química, Universidad de la República, Montevideo, Uruguay | Departamento de Ciencias y Tecnología Farmacéuticas. Facultad de Ciencias Químicas y Farmacéuticas, Universidad de Chile, Santiago, Chile | CIM, Facultad de Ciencias Químicas, Universidad Nacional de Asunción, Asunción, Paraguay | Dpto de Farmacoepidemiología e Información Científica. Dirección de Marketing y Comercialización. Laboratorio de Hemoderivados. Universidad Nacional de Córdoba, Argentina

Note: [] Corresponding author: María Eugenia Olivera, Departamento de Farmacia, Facultad de Ciencias Quimicas, UNC-UNITEFA-CONICET, Haya de la Torre y Medina Allende, Edificio Ciencias II. Ciudad Universitaria (5000), Córdoba, Argentina. Tel./Fax: +54 351 5353865 ext 53360; E-mail: [email protected]

Abstract: Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during 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. The active rol of the universities and drug information centers for/of pharmacovilance seems to be a positive common point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a point to be developed.

Keywords: Drug information services, product surveillance, postmarketing, pharmaceutical industry, public health

DOI: 10.3233/PPL-140390

Journal: Pharmaceuticals, Policy and Law, vol. 16, no. 3-4, pp. 289-312, 2014