Novos medicamentos registrados no Brasil: podem ser considerados como avanço terapêutico?

Abstract

Novos medicamentos registrados no Brasil: podem ser considerados como avanço terapêutico?New medicines registered in Brazil: can they be considered as a therapeutic advance?Resumo Avanços

Governance and pharmacovigilance in Brazil: a scoping review

“…We identified literature that emphasized how transparency was needed in the drug approval process, drug surveillance and regulatory control of medicines [2, 9]. ANVISA’s lack of transparency was noted in the 13th National Conference on Health report [8].…”

Incorporação de novos medicamentos pela Comissão Nacional de Incorporação de Tecnologias do SUS, 2012 a junho de 2016

“…These reports also mention that these drugs would be the object of processes for centralized purchases from abroad, by the Ministry of Health 18,19 . Licensing is an essential regulatory tool in the evaluation of safety, efficacy, and quality of drugs, resulting in the protection of public health 20 . Even taking into account the justifications, medicine incorporation without registration goes against the clearly established criteria in the legal framework for the evaluation of submission for incorporation 5 .…”

Análise de medicamentos novos registrados no Brasil na perspectiva do Sistema Único de Saúde e da carga de doença

“…Studies conducted in Brazil covering the 2000-2004 period identified a small number of drugs with therapeutic advances, and indicated that the pharmaceutical market was not oriented to public health needs 14,15 . Given the above, the objective of this study is to analyze the new drugs registered in Brazil from 2003 to 2013 with regards to the Pharmaceutical Assistance programs of the Unified Health System (SUS), considering the country's burden of disease.…”