Artículos de revistas
Regulatory issues on pharmacovigilance in Latin American countries
Date
2014-10Registration in:
Olivera, Maria Eugenia; Uema, Sonia Andrea Naeko; Romañuk, Carolina Beatriz; Caffaratti, Marina; Carvalho Mastroianni, Patricia; et al.; Regulatory issues on pharmacovigilance in Latin American countries; IOS Press; Pharmaceuticals Policy and Law; 16; 3-4; 10-2014; 289-312
1389-2827
CONICET Digital
CONICET
Author
Olivera, Maria Eugenia
Uema, Sonia Andrea Naeko
Romañuk, Carolina Beatriz
Caffaratti, Marina
Carvalho Mastroianni, Patricia
Rossi Varallo, Fabiana
Vazquez, Marta
Fagiolino, Pietro
Maldonado, Cecilia
Vega, Elena Maria
Vera Galvan, Zully
Maidanag, Mabel
Acostag, Patricia
Rivero, Roxana
Barros, Carolina
Fontana, Daniela
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.