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Gene and cell therapies have transitioned from the research frontier to clinical reality, reshaping the practice of modern medicine. Regulatory authorities across the United States, Europe and Japan have approved a rapidly expanding portfolio of advanced therapy medicinal products (ATMPs), from adeno-associated viral vectors to genome-edited cells.1 Their arrival marks a turning point for personalised care, yet also brings unprecedented operational, educational and ethical challenges. Hospitals must reconcile these transformative treatments with systems designed for conventional pharmaceuticals.2 For pharmacy practice, this is a defining moment: adapting long-established governance models to meet the demands of a new therapeutic era.3