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This article reviews the essential regulatory considerations surrounding medicines and medical devices in Brazil, including clinical trials and marketing authorisations.

Rio de janeiroEstado do rioNational commission for ethicsGood laboratory practicesMinistry of healthWorld health organizationPrinciples of good laboratory practiceTechnological developmentNational health councilTrademark officeNational system of public policies on drugsHandbook good laboratory practicesMinistry of health national immunisation programmeNational council for scientificFederal lawGood laboratory practice