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ICH Project - Technical and regulatory review prior to publication for public consultation by ANVISA

  • Bellan, Natalia (PI)

    Project: Consultancy

    Project Details

    Description

    An ICH guides technical and regulatory analysis project was developed to be internalized in the Brazilian territory by ANVISA. This required a process of technical translation, regulatory review and analysis within the scope of administrative law to ensure compliance of the regulatory agency (ANVISA) with national and international institutions.

    This project was funded by ABIQUIFI.

    Key findings

    The result of this work can be evidenced on the regulatory agency's own website, since the revised and analyzed texts were published by ANVISA: http://portal.anvisa.gov.br/consultas-regionais
    StatusFinished
    Effective start/end date27/03/1731/12/17

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