EMA’s Committee for Advanced Therapies (CAT) announced the availability of a guideline that revises a 2001 “note for guidance” on the quality, preclinical and clinical aspects of gene therapy medicinal products. The announcement contains an overview of relevant comments submitted in mid-2017. EMA explains that the quality section was “completely reworked to give guidance on design, manufacture, characterization and testing of a wider spectrum of delivery vectors (novel viral vectors, non-viral and bacterial vectors). This section has also been formatted using the CTD headings, aiming to provide clear instructions to the applicants how to structure the MAA for their product.”
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