Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in Brazil

• Autor(a) principal: Arrepia, Diva Barrio
• Data de Publicação: 2015
• Outros Autores: Costa, Jorge Carlos, Tabak, David
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/439
• topic: Insumo; Isonomia; Fabricação; Importação; Registro; Active; Isonomy; Production; Importation; Registration

The aim of the study was to investigate the potential contribution that the obligatory registration of active pharmaceutical ingredients (APIs) had on the establishment of regulatory isonomy between API producers in Brazil and international producers. In addition, this study aimed to evaluate the effect of this isonomy on the re-establishment of local production. The investigation identified the registration of 20 APIs, defined as priorities by the Brazilian National Agency for the Sanitary Surveillance (ANVISA), in the period 2010–2012. The methodology used included the collection of data from national and international, public and private, databases that allowed the construction of tables and graphs. The results demonstrated that registration of APIs is an important instrument for public politics leading to regulatory isonomy. However, the period under analysis was not sufficiently long to confirm that the RDC, combined with other governmental actions, may have promoted the increase in production, although some signs exist that this will eventually happen.