Journal
HUMAN GENE THERAPY CLINICAL DEVELOPMENT
Volume 24, Issue 2, Pages 47-54Publisher
MARY ANN LIEBERT, INC
DOI: 10.1089/humc.2013.119
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Funding
- Medical Research Council [MR/K000608/1] Funding Source: Medline
- Medical Research Council [MR/K000608/1] Funding Source: researchfish
- MRC [MR/K000608/1] Funding Source: UKRI
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In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also takes the lead in defining the scientific framework for the quality, nonclinical and clinical development of such products. This reflection paper represents the Committee's current thinking on management of clinical risks deriving from insertional mutagenesis. A multidisciplinary approach to insertional mutagenesis is provided. This reflection paper has been adopted by the committee in its April 2013 meeting.
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