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    Worksharing in the Evaluation of Active Substances

    This article describes ongoing procedures and initiatives for 'worksharing' in the evaluation of active substance dossiers by regulatory authorities around the world. Introduction An Active Substance or Drug Master File (ASMF/DMF) can be used to describe the chemistry, manufacture and controls for an active substance. It is typically divided into an applicant's or open part and a restricted or closed part. The applicant's part is provided to the Marketing Authorizatio...