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This Concept Paper proposes a revision of the Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products (CPMP/BWP/3088/99) that came into effect in 2001. 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. The revised Guideline will refer to a number of recently developed scientific guidelines and will comply with Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products and the Commission Directive 2009/120/EC amending of the Annex I Part IV of Directive 2001/83/EC

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