Regulatory issues on pharmacovigilance in Latin American countries

OLIVERA MARÍA EUGENIA; UEMA SONIA ANDREA NAEKO; ROMAÑUK CAROLINA BEATRIZ; CAFFARATTI MARIANA; CARVALHO MASTROIANNI PATRICIA; ROSSI VARALLO FABIANA; VAZQUEZ MARTA; FAGIOLINO PIETRO; MALDONADO C; VEGA ELENA MARÍA; VERA GALVAN ZULLY; MAIDANA M; ACOSTA PATRICIA; RIVERO ROXANA; BARROS CAROLINA; FONTANA DANIELA

Pharmaceuticals Policy and Law

IOS Press

Lugar: Amsterdam; Año: 2014 vol. 16 p. 298 - 298

1389-2827

harmacovigilance 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.