title: Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA).
abstract: Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal.Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015.Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015.Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.
authors.affiliation: Office of Assessment of Synthetic Drugs Pharmaceutical Technology, General Office of Drug Products, Brazilian Health Regulatory 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: Ana Cerúlia Moraes
authors.initials: AC
authors.lastname: do Carmo
authors.affiliation: Office of Assessment of Synthetic Drugs Pharmaceutical Technology, General Office of Drug Products, Brazilian Health Regulatory Agency, ANVISA, Brasília, DF, Brazil.
authors.forename: Stefânia Schimaneski
authors.initials: SS
authors.lastname: Piras
authors.affiliation: Office of Assessment of Synthetic Drugs Pharmaceutical Technology, General Office of Drug Products, Brazilian Health Regulatory Agency, ANVISA, Brasília, DF, Brazil.
authors.forename: Nayrton Flávio Moura
authors.initials: NF
authors.lastname: Rocha
authors.affiliation: Laboratory of Food, Drugs and Cosmetics (LTMAC), School of Health Sciences, University of Brasília (UnB), Brasília, DF, Brazil.
authors.forename: Tais
authors.identifier: 0000-0001-6481-2364
authors.initials: T
authors.lastname: Gratieri
mesh_terms: D001938:Brazil; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic / Q000494:pharmacology*; D040541:Marketing
chemical_list: D016568:Drugs, Generic