Anvisa publica guias sobre medicamentos e produtos biológicos

Publicado 16/10/2015

Já estão disponíveis, no site da Anvisa, três guias relacionados a medicamentos e produtos biológicos. Os documentos expressam o entendimento da Agência sobre procedimentos e métodos considerados adequados ao cumprimento de requisitos exigidos pela legislação.

Os guias tratam dos seguintes temas: “Elaboração do Relatório Sumário de Validação de Processo de Fabricação de Medicamentos”; “Qualificação de Transporte dos Produtos Biológicos” e “Desfechos para Estudos Clínicos de Medicamentos Oncológicos”.

A adoção dos guias como instrumento regulatório foi decidida durante a reunião da Diretoria Colegiada do dia 30 de junho deste ano. O objetivo é de permitir que a Agência tenha a opção de tratar de temas de interesse sanitário de forma complementar ou mesmo alternativa às medidas de regulamentação tradicionais. Com isso, a Anvisa busca trazer harmonização e segurança jurídica aos seus processos regulatórios.

Conforme o fluxo aprovado pelos diretores, os guias tornam-se vigentes a partir da publicação no portal da Anvisa, porém ficam sujeitos ao recebimento de contribuições por período determinado em sua aprovação.

Um link específico foi criado para disponibilizar estes Guias e os futuros no Portal da Agência. Clique aqui e obtenha outras informações sobre o tema.

Fonte: Anvisa

Foto: Freepik



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