title: An Update of the Brazilian Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products.
abstract: This note aims to clarify the Brazilian regulatory bioequivalence recommendations for approval of generic topical dermatological drug products, since the legal framework of the "Brazilian Health Surveillance Agency" (ANVISA) is only available in Portuguese. According to Resolutions RE n. 1170 (December 19th 2006) and RDC n. 37 (August 3rd 2011) in Brazil, only in vitro studies are required for registration of generic topical dermatological drug products. Current Regulatory Agenda of ANVISA, which contains possible future resolutions to be revised over 2015-2016, includes a discussion on biowaiver requirements and on possible in vitro and in vivo comparability tests for these products.
authors.affiliation: Coordination of Therapeutic Equivalence, General Office of Medicines, Brazilian Health Surveillance Agency (ANVISA), Brasília, DF, Brazil.|Laboratory of Food, Drugs and Cosmetics (LTMAC), School of Health Sciences, University of Brasília (UnB), Brasília, DF, Brazil.
authors.forename: Kelen Carine Costa
authors.initials: KC
authors.lastname: Soares
authors.affiliation: Coordination of Therapeutic Equivalence, General Office of Medicines, Brazilian Health Surveillance Agency (ANVISA), Brasília, DF, Brazil.
authors.forename: Gustavo Mendes Lima
authors.initials: GM
authors.lastname: Santos
authors.affiliation: Laboratory of Food, Drugs and Cosmetics (LTMAC), School of Health Sciences, University of Brasília (UnB), Brasília, DF, Brazil.
authors.forename: Guilherme M
authors.initials: GM
authors.lastname: Gelfuso
authors.affiliation: Laboratory of Food, Drugs and Cosmetics (LTMAC), School of Health Sciences, University of Brasília (UnB), Brasília, DF, Brazil. tgratieri@gmail.com.
authors.forename: Tais
authors.initials: T
authors.lastname: Gratieri
mesh_terms: D000287:Administration, Topical; D001938:Brazil; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000592:standards*; D017277:Drug Approval / Q000379:methods*; D016568:Drugs, Generic / Q000592:standards*; D006801:Humans; D013810:Therapeutic Equivalency
chemical_list: D003879:Dermatologic Agents; D016568:Drugs, Generic
keywords: bioequivalence; generic; topic