This document defines scientific principles and provides guidance to applicants developing Gene Therapy medicinal products (GTMPs). It focuses on the non-clinical studies required before the first use of a GTMPs in human subjects.
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Guideline On The Non-Clinical Studies Required Before First Clinical Use Of Gene Therapy Medicinal Products
Published by EMA
Advanced TherapyRegulatory AffairsEarly Access SupportGene TherapyNon-ClinicalFirst Clinical Use