title: [Generic drugs in Brazil: historical overview and legislation].
abstract: 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.
authors.affiliation: Departamento de Farmácia, Escola de Farmácia, Universidade Federal de Ouro Preto, Ouro Preto, MG, Brasil.
authors.forename: Lorena Ulhôa
authors.initials: LU
authors.lastname: Araújo
authors.forename: Kemile Toledo de
authors.initials: KT
authors.lastname: Albuquerque
authors.forename: Kelly Cristina
authors.initials: KC
authors.lastname: Kato
authors.forename: Gleiciely Santos
authors.initials: GS
authors.lastname: Silveira
authors.forename: Náira Rezende
authors.initials: NR
authors.lastname: Maciel
authors.forename: Pollyanna Álvaro
authors.initials: PÁ
authors.lastname: Spósito
authors.forename: Neila Márcia Silva
authors.initials: NM
authors.lastname: Barcellos
authors.forename: Jacqueline de
authors.initials: Jd
authors.lastname: Souza
authors.forename: Márcia
authors.initials: M
authors.lastname: Bueno
authors.forename: Sílvia
authors.initials: S
authors.lastname: Storpirtis
mesh_terms: D001682:Biological Availability; D001702:Biopharmaceutics / Q000145:classification; D001938:Brazil; D004348:Drug Labeling; D016568:Drugs, Generic / Q000266:history* / Q000493:pharmacokinetics; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D007880:Legislation, Drug / Q000266:history*; D013810:Therapeutic Equivalency
chemical_list: D016568:Drugs, Generic