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In the European Union, such products are regulated under the Advanced Therapy Medicinal Products (ATMP) framework, subject to centralized review by the European Medicines Agency (EMEA) and its expert committees, with specific guidelines applicable to gene therapies and similar products [168]

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Abstract Clinical application of anticancer agents has been often hampered by toxicity against normal cells, so the achievement of their cancer-specific action is still one of the major challenges to be addressed