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REVISTA FACTO

Jul-Set 2017 • ANO XI • ISSN 2623-1177

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//Abifina em Ação

GGMED e ABIFINA debatem temas de medicamentos e IFAs 3j385c

Representantes de todas as empresas associadas da ABIFINA nos segmentos farmacêutico e farmoquímico participaram da reunião do Comitê Farmo realizada no dia 19 de setembro, na sede da Agência Nacional de Vigilância Sanitária (Anvisa), em Brasília. Coordenado pela analista técnica da Associação Marina Moreira, o encontro teve por objetivo entender a nova estrutura da Gerência-Geral de Medicamentos e Produtos Biológicos (GGMED) da Anvisa, entre outros temas. As questões foram esclarecidas pelo gerente-geral da área, Varley Dias Sousa, e outros dirigentes.

Na área de medicamentos, a Anvisa está ajustando o fluxo de análise das petições de concessão e de renovação de registro para atender à regulação vigente. Quanto ao registro e pós-registro, está em andamento o projeto de agrupamento de petições por áreas para sanar o atraso nas análises.

Ressaltou-se a importância de os associados observarem o Edital de Chamamento nº 11/2017 (interesse em manter ou desistir do processo para genéricos e similares).

Já no segmento farmoquímico, a Anvisa expressou que, em casos excepcionais, poderá dispensar a apresentação dos testes microbiológicos, desde que haja uma justificativa robusta. Sobre a revisão da RDC 57/2009 (registro de insumos farmacêuticos ativos – IFAs), a proposta ainda está sendo estudada, enquanto a possibilidade de auditorias pós-registro deve ser retomada em 2018.

Regulatório Agro tem destaque na agenda institucional 6u2g3b

Gestão do FNDCT está em debate no setor produtivo e academia 1h2939