Brazil is gaining its momentum in pharmaceutical development

Ana Paula Ruenis, João Massud Filho

Abstract

Brazil is one of the world´s largest economies and pharmaceutical markets, having the Brazilian government as an important purchaser. There are strong local companies that have grown sustainably after the introduction of generics and are investing in both incremental and radical innovation. However, research and development (R&D) expenditures are still modest; this could be explained by a combination of economic and political uncertainty in the past few years and a bureaucratic, complex regulatory framework. New regulations, efforts to reduce ethical and regulatory review timelines, and a Senate bill aimed to accomplish that goal should constitute the definitive regulatory landmark for boosting clinical research. In addition to government investments they have given a breath of relief in the market, as Brazil is trying to, once again, gain momentum as a “must-go” country for clinical development. Non-profit associations such as the Brazilian Society of Pharmaceutical Medicine (Sociedade Brasileira de Medicina Farmacêutica-SBMF), the Brazilian Association of CROs (Associação Brasileira de Organizações Representativas de Pesquisa Clínica-ABRACRO), the Brazilian Clinical Research Alliance (Aliança Pesquisa Clínica Brasil), amongst others, helped to give the impulse to trigger such changes. It is time to invest heavily in developing educational programs to address the growing need for clinical development scientists and physicians.

Keywords

clinical trials; Brazil; regulatory; SBMF; ABRACRO; Aliança Pesquisa Clínica Brasil

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References

World Bank Data: Brazil overview, n.d., viewed June 3, 2016,

Afonso P, Dreszer J, Francis T, et al. 2014, Maintaining momentum in Brazil’s pharmaceutical market, McKinsey & Company, viewed June 3, 2016,

PricewaterhouseCoopers Brasil, 2015, O setor farmacêutico no Brasil, viewed June 7, 2016,

ClinicalTrials.gov, n.d., viewed June 8, 2016,


DOI: http://dx.doi.org/10.18063/JMDS.2016.01.005
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Copyright (c) 2016 Ana Paula Ruenis, João Massud Filho

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