Revista Panamericana de Salud Pública
Print version ISSN 1020-4989
ARAUJO, Lorena Ulhôa et al. Generic drugs in Brazil: historical overview and legislation. Rev Panam Salud Publica [online]. 2010, vol.28, n.6, pp. 480-492. ISSN 1020-4989. http://dx.doi.org/10.1590/S1020-49892010001200010.
The Brazilian generic drugs policy was implemented in 1999 with the aim of stimulating competition in the market, improve the quality of drugs and improve the access of the population to drug treatment. The process of implementing this policy allowed the introduction and discussion of concepts that had never before been used in the context of drug registration in Brazil: bioavailability, bioequivalence, pharmaceutical equivalence, generic drugs, biopharmaceutical classification system, biowaiver. The present article provides definitions for these concepts in the context of Brazilian legislation as well as a historical and chronological description of the implementation of the generic drugs policy in Brazil, including a list of current generic drug legislation. This article contributes to the understanding of the Brazilian generic drugs policy and facilitates the search for information concerning the legal requirements for registration of drugs in Brazil.
Keywords : therapeutic equivalency; biological availability; drugs, generic; legislation; Brazil.