Manual de Análise de Insumos Farmacêuticos disponível

Já está disponível o Manual de Análise de Insumos Farmacêuticos Ativos (IFA) para orientar interessados e fabricantes sobre o registro de insumos. O manual é eletrônico e tem como objetivo principal uniformizar a análise do DMF (Arquivo Mestre da Droga, na sigla em inglês), que é um documento base sobre o registro de insumos farmacêuticos.

O insumo farmacêutico ativo é a substância que dá ao medicamento a sua característica farmacêutica. Ou seja o que faz com que um medicamento funcione.

Manual

publicação traz um visual atraente, com estrutura em abas que facilitam a consulta. Para a sua elaboração foi considerada a legislação sanitária atual do país, o modelo de análise do International Generic Drug Regulators Programme (IGDRP), e a própria experiência acumulada pela Anvisa no Programa de Pré-Qualificação de Medicamentos da OMS.

O Manual de IFAs, também considera os guias das principais autoridades no mundo sobre o tema: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH); Agência Europeia de Medicamentos (EMA); Organização Mundial da Saúde (OMS); Diretoria Europeia para Qualidade de Medicamentos (EDQM) e a Agência de Saúde do Canadá.

O lançamento deste produto aconteceu no último dia 26 de julho pela Coordenação de Registro de Insumos Farmacêuticos Ativos (COIFA/GGMED).

Atualização contínua

Mesmo em processo contínuo de construção, o manual inova ao trazer ainda mais transparência ao procedimento de análise de registro de insumos farmacêuticos ativos (IFAs), além de ser mais uma ferramenta para agilizar os processos de trabalho na Anvisa, reduzindo o número de exigências técnicas e, consequentemente, o prazo de análise dos dossiês.

O processo regulatório das IFAs é complexo e por isso é importante que os solicitantes de registro de IFAs e fabricantes atuem de forma pró-ativa, dando acesso a documentação completa dos seus produtos.

O Manual de IFA está sujeito a atualização constante. Dúvidas, correções e sugestões podem ser enviada para o endereço coifa@anvisa.gov.br, por meio da associação que representa a empresa.

Acesse o manual: http://www20.anvisa.gov.br/coifa/index.html (Utilizar o navegador Google Chrome).

Com informações da Assessoria de Imprensa da Anvisa



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