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Focus on Regulation

Tag Archives: gene therapy

EMA launches public consultation on draft Guideline concerning the development of GTMPs

On 20 May 2015, the European Medicines Agency (“EMA”) launched a three month consultation on a revised Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products. Once finalised, the draft Guideline will replace the 2001 Note for guidance on the quality, preclinical and clinical aspects of gene therapy medicinal products. The