Brasil | Artículos de revistas

Regulatory issues on pharmacovigilance in Latin American countries

dc.contributorUniversidad Nacional de Córdoba
dc.contributorUniversidade Estadual Paulista (Unesp)
dc.contributorUniversidad de la República
dc.contributorUniversidad de Chile
dc.contributorUniversidad de Assunción
dc.date.accessioned2016-01-28T16:56:41Z
dc.date.available2016-01-28T16:56:41Z
dc.date.created2016-01-28T16:56:41Z
dc.date.issued2014
dc.identifierPharmaceuticals Policy and Law, v. 16, p. 289-312, 2014.
dc.identifier1389-2827
dc.identifierhttp://hdl.handle.net/11449/133808
dc.identifier10.3233/PPL-140390
dc.identifier4160558780902988
dc.identifier0000-0001-8467-7278
dc.description.abstractPharmacovigilance 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.
dc.languageeng
dc.publisherNetwork of Centres for Study of Pharmaceutical Law
dc.relationPharmaceuticals Policy and Law
dc.relation0,102
dc.rightsAcesso restrito
dc.sourceCurrículo Lattes
dc.subjectDrug information services
dc.subjectProduct surveillance
dc.subjectPostmarketing
dc.subjectPharmaceutical industry
dc.subjectPub-lic health
dc.titleRegulatory issues on pharmacovigilance in Latin American countries
dc.typeArtículos de revistas


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