Guide for the development and evaluation of Gene Therapy Medicinal Products (GTMPs) intended for use in humans and presented for Marketing Authorisation Application (MAA). Its focus is on the quality, Safety and efficacy requirements of GTMPs.
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Quality, preclinical and clinical aspects of Gene Therapy medicinal products
Published by EMA
Quality GuidelineRegulatory AffairsAdvanced TherapyGene TherapyATMPNon-Clinical