chapter  3
21 Pages

Brazil

ByMargareth R. C. Marques, Sı´lvia Storpirtis, and Ma´rcia Martini Bueno

INTRODUCTION The publication of the National Policy for Drug Products in 1998, the creation of the National Agency for Sanitary Surveillance or Agencia Nacional de Vigilancia Sanitaria (ANVISA), the approval of the law, and the publication of the technical guidances for the registration of generic products dramatically changed the pharmaceutical market in Brazil. New concepts such as pharmaceutical equivalency, therapeutic equivalency, bioavailability, and bioequivalence were introduced (1-4).