Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU
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Publisher
Springer Berlin Heidelberg
Link
https://link.springer.com/content/pdf/10.1007/164_2023_648
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3. Alliance for Regenerative Medicine, European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for Bioindustries (EuropaBio), Beattie S, Hubert A, Morrell J, Cook JA, Werner M, Ginty P, Butler G, Dahy A, Coutinho V, Roberts N, Rabbie D, Gaido M, Huh S, Olivia L, Georgieva V, Lambot N, Reimer T, de Goeij I, Romanetto J, Acha V, Tellner P (2021) Call for more effective regulation of clinical trials with advanced therapy medicinal products consisting of or containing genetically modified organisms in the European Union. Hum Gene Ther 32(19–20):997–1003. https://doi.org/10.1089/hum.2021.058
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5. Coppens DGM, Hoekman J, De Bruin ML, Slaper-Cortenbach ICM, Leufkens HGM, Meij P, Gardarsdottir H (2020) Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries. Cytotherapy 22(10):592–600. https://doi.org/10.1016/j.jcyt.2020.04.092
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2. Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries;Frontiers in Pharmacology;2023-11-28
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