Quality, preclinical and clinical aspects of gene therapy medicinal products - Scientific guideline

This guideline is a revision of the Note for Guidance on the Quality, Preclinical and Clinical aspects of gene transfer medicinal products (CPMP/BWP/3088/99), which was published in 2001. It defines scientific principles and provides guidance 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.

Keywords: Gene therapy medicinal products, advanced therapy medicinal products (ATMPs), quality, non-clinical, clinical

Document history - Revision 1 (current)


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