Market authorization scenario for synthetic and semisynthetic drug products in Brazil

• Autor(a) principal: Franca, Juçara Ribeiro
• Data de Publicação: 2021
• Outros Autores: Moraes Carmo, Ana Cerúlia, Sanches Pereira, Raphael
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1718
• topic: Registro; Medicamentos Genéricos; Medicamentos Similares; Medicamento Novos; Política Nacional de Medicamento Genéricos; Anvisa; Market Authorization; Generic Drug Products; Similar Drug Products; New Drug Application; National Police for Generic Drugs; Anvisa

Introduction:Market authorization is the government approval needed for drug product commercialization in Brazil. The requirements for market authorization were reorganized in 1999, when the Brazilian Health Regulatory Agency (Anvisa) was created and, also, when the National Police for Generic Drugs was implemented. Objective:About 20 year after the implementation of the Police and the creation of Anvisa, this work aimed to describe the current scenario of market authorization for synthetic and semisynthetic drug products. This scenario aims to aid the decision-making process of regulators and regulated. Method:We used the System of Product and Services under Health Surveilance (Datavisa) to perform the data survey regarding valid market authorizations. Access to this database is exclusive to Anvisa’s employees. Results:We found 6,454 valid market authorizations, accounting for 7,721 different drug products. More than 80,0% of the  market authorizations are for generic and similar drug products. The   national companies play an important role in the Brazilian pharmaceutical market, but we still identified some difficulty related to innovation. Among the main approved categories, we could find several over-the-counter drug products and, also, antibacterials for systemic use, drug products with action in the central nervous system, antineoplasic agents, and drug product for management of metabolic syndrome. The diseases treated by these drugs are highly prevalent in Brazil. Conclusions:The data showed the effectiveness of the adopted policies and can be used in the formulation of new policies related to the regularization of drug product in Brazil.