title: [Bioequivalence of dermatological topical medicines:the Brazilian scenario and the challenges for health surveillance].
abstract: The comparative evaluation required for the registration of generic topical medicines in Brazil is conducted by means of a pharmaceutical equivalence study, which merely assesses the physical/chemical and microbiological parameters of the formulations. At the international level, clinical or pharmacodynamic studies are now being required to prove the efficacy and safety of semisolid topical generic formulations. This work presents a comparison of the different requirements for the registration of topical formulations, taking into consideration the various regulatory authorities, and presents a survey of topical medicines registered in Brazil prior to 2013. The survey revealed that in comparison with the USA there were many more copies of these formulations registered in Brazil. This fact, together with the large number of studies in the literature showing the lack of bioequivalence of topical medication, is clear proof of the major importance of the need to realign Brazilian legislation with respect to the technical requirements for the registration of generic and similar medication for dermatological topical application in Brazil.
authors.affiliation: Laboratório de Tecnologia de Medicamentos, Alimentos e Cosméticos, Faculdade de Ciências da Saúde, Universidade de Brasília, Brasília, DF, Brasil, kelen.soares@anvisa.gov.br.
authors.forename: Kelen Carine Costa
authors.initials: KC
authors.lastname: Soares
authors.affiliation: Laboratório de Tecnologia de Medicamentos, Alimentos e Cosméticos, Faculdade de Ciências da Saúde, Universidade de Brasília, Brasília, DF, Brasil, kelen.soares@anvisa.gov.br.
authors.forename: Marcelo Vogler
authors.initials: MV
authors.lastname: Moraes
authors.affiliation: Laboratório de Tecnologia de Medicamentos, Alimentos e Cosméticos, Faculdade de Ciências da Saúde, Universidade de Brasília, Brasília, DF, Brasil, kelen.soares@anvisa.gov.br.
authors.forename: Guilherme Martins
authors.initials: GM
authors.lastname: Gelfuso
authors.affiliation: Laboratório de Tecnologia de Medicamentos, Alimentos e Cosméticos, Faculdade de Ciências da Saúde, Universidade de Brasília, Brasília, DF, Brasil, kelen.soares@anvisa.gov.br.
authors.forename: Taís
authors.initials: T
authors.lastname: Gratieri
mesh_terms: D000287:Administration, Topical; D001938:Brazil; D016568:Drugs, Generic; D006801:Humans; D012871:Skin Diseases / Q000188:drug therapy*; D013810:Therapeutic Equivalency; D014481:United States
chemical_list: D016568:Drugs, Generic