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Eficiência Regulatória: Análise de Sobrevivência Aplicada a Trajetória de Registro de Medicamentos Genéricos

  • Mônica da Luz Carvalho Soares
  • Leila Posenato Garcia
  • Sâmia Rocha de Oliveira Melo
  • Daniela Barros Rocha
  • Stefania Schimaneski Piras
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    Ao longo dos últimos anos, um novo e desafiante cenário no registro de medicamentos genéricos vem sendo gradativamente incorporado na rotina de análise dos dossiês de registro apresentados à Agência Nacional de Vigilância Sanitária (Anvisa) pela indústria farmacêutica, no Brasil. Neste trabalho, são calculados os prazos para obtenção de registro de medicamentos genéricos e os principais pontos envolvidos no ganho ou na perda de eficiência neste processo. São apresentados os conceitos atuais incorporados na regulação dos medicamentos genéricos, tais como genéricos inéditos, medicamentos priorizados e medicamentos clones. A amostra foi composta por 323 medicamentos genéricos registrados em 2010. Para análise dos dados, foi estimado um modelo de sobrevivência que contemplou os parâmetros envolvidos na trajetória de registro de um medicamento genérico. Como principais resultados, foram encontrados períodos para obtenção de registro na Anvisa de até 626 dias para medicamentos não priorizados e 429 dias para medicamentos com análise priorizada - que, porém, diminuíram para 323 dias com os procedimentos de análise in loco (auditorias de registro), e aumentaram para 1.018 dias com arquivamentos temporários solicitados pelas indústrias farmacêuticas. Um dado inesperado foi a quantidade de processos arquivados/encerrados pelas empresas farmacêuticas (26% do total de processos auditados) após as auditorias de registro. Conclui-se que os resultados encontrados apontam para mudanças racionais nos procedimentos de registro de medicamentos genéricos no Brasil com foco nas auditorias de registro e na qualidade dos dossiês de registro apresentados pela indústria farmacêutica. A new and challenging scenario for drug analysis and registration has been gradually incorporated into the routine of the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitára - Anvisa) by the Brazilian pharmaceutical industry. This text calculates how long the registration process for generic drugs lasts and analyzes the most important issues involved. We discuss the mains concepts involved in regulation of generic and similar drugs such as: original generic drugs, prioritizedorial department. generic drugs, and clone. The sample analyzed is composed of 323 generic drugs registered in 2010. A survival model involving the most important parameters in the registration process was estimated. The main results are that the average registration time is 626 for non-prioritized drugs and 429 for prioritized ones. Drugs suffering on location audits were analyzed on average in 323 days and drugs with temporary process suspension at the request of the industry were analyzed in 1018 days on average. An unexpected result is that 26% of the audited drugs were suspended at the request of the industry after the audits. We conclude that these results point to a window of opportunity for rational changes in the registration process for drug copies in Brazil focused on audits and the quality of information provided by the pharmaceutical industry.

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    Paper provided by Instituto de Pesquisa Econômica Aplicada - IPEA in its series Discussion Papers with number 1774.

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    Length: 38 pages
    Date of creation: Sep 2012
    Date of revision:
    Handle: RePEc:ipe:ipetds:1774
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