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Eudralex Volume 3 Concept Paper for the revision of Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products


European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium),

Document Type:
Concept Paper
The revision of the Note for Guidance, Guideline according to the new terminology, will address the issues identified from clinical experience and provision of Scientific Advice on gene therapy medicinal products and will lay down detailed and updated requirements for the quality, nonclinical and clinical aspects of gene therapy medicinal products.

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