Analysis of the regulatory scenario for the renewal of registration of generic and similar drugs at the National Health Surveillance Agency: subsidy to the health regulation of post-registration of drugs

• Autor(a) principal: Oliveira, Henrique Mansano Rosa
• Data de Publicação: 2020
• 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/1323
• topic: Renovação de Registro; Legislação Sanitária; Revalidação Automática; Registro de Produtos; Medicamentos; Agência Nacional de Vigilância Sanitária; Renewal of Registration; Health Legislation; Automatic revalidation; Product Registration; Medicines; Brazilian Health Regulatory Agency

Introduction: The publication of the Resolution of the Collegiate Directorate of the Brazilian Health Regulatory Agency (Anvisa) Nº. 200, of December 26, 2017, made the analysis of petitions for renewing the registration of medicines would become a lesser activity complexity. However, the number of automatic registration revalidations remains expressive. In addition, rejections of these petitions continue to occur. Objective: Characterize the outcomes of the analyzes of these renewals and quantify the number of automatic renewals of registration of generic and similar drugs. Method: Retrospective analysis of requests for renewal of registration of generic drugs and similar procedures processed by the General Office of Medicines and Biological Products (GGMED) Anvisa, from January 2017 to August 2018. The information was obtained in the system Datavisa, from Anvisa, after GGMED and the Coordination of Institutional Security (CSEGI) authorized access. Results: In the period from January 2017 to August 2018 processed through GGMED 1,450 requests for renewal of medication registration generics and the like. A considerable percentage of automatic revalidations was observed medication registration, since 378 (26,0%) petitions among those processed by GGMED in the study period were automatically revalidated. An expressive portion was found of medicinal products belonging to the similar category, 247 petitions, corresponding to 65,0% of the 378 petitions renewed automatically. In the set of analyzed and rejected petitions, the main reasons for rejections were related with technical-administrative reasons (36 petitions, out of 51 rejected). Conclusions: The automatic registration revalidations, which should be an exception possibly if became the rule. Fact that brings concern from the health point of view.