Pizevska Maja, Kaeda Jaspal, Fritsche Enrico, Elazaly Hisham, Reinke Petra, Amini Leila
Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin Institute of Health Center for Regenerative Therapies, Berlin, Germany.
Berlin Center for Advanced Therapies (BeCAT), Charité-Universitätsmedizin Berlin, Berlin, Germany.
Front Med (Lausanne). 2022 Feb 3;9:757647. doi: 10.3389/fmed.2022.757647. eCollection 2022.
Advanced Therapy Medicinal Products (ATMPs) comprising cell, gene, and tissue-engineered therapies have demonstrated enormous therapeutic benefits. However, their development is complex to be managed efficiently within currently existing regulatory frameworks. Legislation and regulation requirements for ATMPs must strike a balance between the patient safety while promoting innovations to optimize exploitation of these novel therapeutics. This paradox highlights the importance of on-going dynamic dialogue between all stakeholders and regulatory science to facilitate the development of pragmatic ATMP regulatory guidelines.
包含细胞、基因和组织工程疗法的先进治疗药品（ATMPs）已展现出巨大的治疗益处。然而，在当前现有的监管框架内，其开发过程复杂，难以有效管理。ATMPs的立法和监管要求必须在保障患者安全的同时促进创新，以优化这些新型疗法的利用。这一矛盾凸显了所有利益相关者与监管科学之间持续动态对话对于制定务实的ATMP监管指南的重要性。
