2 resultados para regulatory policy

em Repositório Institucional UNESP - Universidade Estadual Paulista "Julio de Mesquita Filho"


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Brazil, one of the world's largest developing countries, has recently introduced a new solid waste management regulatory policy. This new regulatory policy will have implications for a wide variety of stakeholders and sets the stage for opportunities and lessons to be learned. These issues are discussed in this article. © 2013 Springer-Verlag Berlin Heidelberg.

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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.