Regulatory issues on pharmacovigilance in Latin American countries
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Data
2014
Autores
Olivera, María Eugenia
Uema, Sonia Andrea Naeko
Romañuk, Carolina Beatriz
Caffaratti, Mariana
Mastroianni, Patricia de Carvalho [UNESP]
Varallo, Fabiana Rossi [UNESP]
Vazquez, Marta
Fagiolino, Pietro
Maldonado, Cecilia
Vega, Elena María
Título da Revista
ISSN da Revista
Título de Volume
Editor
Network of Centres for Study of Pharmaceutical Law
Resumo
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.
Descrição
Palavras-chave
Drug information services, Product surveillance, Postmarketing, Pharmaceutical industry, Pub-lic health
Como citar
Pharmaceuticals Policy and Law, v. 16, p. 289-312, 2014.