Regulatory issues on pharmacovigilance in Latin American countries
Pharmaceuticals Policy and Law, v. 16, p. 289-312, 2014.
Olivera, María Eugenia
Uema, Sonia Andrea Naeko
Romañuk, Carolina Beatriz
Mastroianni, Patricia de Carvalho
Varallo, Fabiana Rossi
Vega, Elena María
Galvan, Zully Vera
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.