학술논문
Regulatory issues on pharmacovigilance in Latin American countries.
Document Type
Article
Author
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
Source
Subject
*DRUG laws
*MEDICATION safety
*CLINICAL trials
*PHARMACEUTICAL industry
*PUBLIC health
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Language
ISSN
1389-2827
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. [ABSTRACT FROM AUTHOR]