Unité de thérapie cellulaire, université de Paris, hôpital Saint-Louis, AP-HP, 75010 Paris, France; Inserm, centre d'investigation clinique de biothérapies CBT501 et U976, 75010 Paris, France.
Pharmacie à usage intérieur, université de Paris, hôpital Saint-Louis, AP-HP, 75010 Paris, France.
Therapie. 2022 Mar-Apr;77(2):185-190. doi: 10.1016/j.therap.2021.11.005. Epub 2021 Nov 26.
Advanced therapy medicinal products (ATMPs) represent a new class of biological medicines. The European regulation has classified ATMPs into three categories: gene therapy medicinal products, somatic cell therapy medicinal products, and Tissue-Engineered products. If one of these categories incorporates a medical device, the medicine is defined as a Combined ATMP. The specificity and complexity of these innovative drugs have required a complete reorganization of hospital and pharmaceutical circuits, from patient eligibility to drug administration. Indeed, increased interaction and collaboration between different healthcare professionals are essential in order to guarantee quality and safety of these innovative medicines.
先进治疗药物（ATMPs）代表了一类新型的生物药物。欧洲法规将 ATMP 分为三类：基因治疗药物、体细胞治疗药物和组织工程产品。如果这些类别中的任何一种包含医疗器械，则该药物被定义为组合 ATMP。这些创新药物的特异性和复杂性要求对医院和制药行业的各个环节进行全面重组，从患者资格到药物管理。事实上，为了保证这些创新药物的质量和安全性，不同医疗保健专业人员之间的更多互动和协作是必不可少的。
