Advanced therapy medicinal products: Regulatory framework, hospital and pharmaceutical circuits in Europe and France - 05/04/22
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Summary |
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.
Le texte complet de cet article est disponible en PDF.Keywords : Advanced therapy medicinal products, Pharmaceutical and hospital circuits, European and French regulation
Plan
Vol 77 - N° 2
P. 185-190 - mars 2022 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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