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The document discusses the regulatory perspective of the European Medicines Agency (EMA) on genome-editing medicinal products (GEMPs) like CRISPR–Cas9, highlighting the challenges in quality control, non-clinical development, and clinical trials. It emphasizes the importance of addressing off-target toxicity, product characterization, and the need for tailored support from regulatory authorities. The recent approval of Casgevy for sickle cell disease marks a significant milestone in the development of GEMPs

Author

bahar

Language

EN