UNITEFA 23945
UNIDAD DE INVESTIGACION Y DESARROLLO EN TECNOLOGIA FARMACEUTICA
Unidad Ejecutora - UE
artículos
Título:
Regulatory issues on pharmacovigilance in Latin American countries
Autor/es:
OLIVERA ME; UEMA SAN; ROMAÑUK CB; CAFFARATTI M; CARVALHO MASTROIANNI P; ROSSI VARALLO F; VAZQUEZ M; FAGIOLINO P; MALDONADO C; VEGA EM; VERA GALVAN Z; MAIDANA M; ACOSTA P; RIVERO R; BARROS C; FONTANA D
Revista:
Pharmaceuticals Policy and Law
Editorial:
IOS Press
Referencias:
Lugar: Amsterdam; Año: 2014 vol. 16 p. 289 - 312
ISSN:
1389-2827
Resumen:
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.
