Abstract
Preclinical tests in Brazil
Highlights
The Brazilian pharmaceutical industry went through different phases, which reflected, at least in part, national economic stages
This has been changing as some national companies, supported by the federal government, have started developing new molecules derived from academic research, as well as producing drugs whose patents have expired
Other actions were reinforced, such as the introduction of Good Laboratory Practice (GLP) by INMETRO, the search of bilateral recognition for toxicology studies between Brazil and OECD, the release of the Guidelines for nonclinical security studies required for drug development by ANVISA, and the establishment of the regulatory agency for animal facilities (Conselho Nacional de Controle de Experimentação Animal CONCEA), created in 2008 with the approval of the “Arouca” Law
Summary
The Brazilian pharmaceutical industry went through different phases, which reflected, at least in part, national economic stages. This has been changing as some national companies, supported by the federal government, have started developing new molecules derived from academic research, as well as producing drugs whose patents have expired.
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