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Spain lets hospitals make and use their own CAR-T under a special rule; most European countries do not. A common rule with shared outcome tracking would spread affordable academic products.
The EU ATMP Regulation's hospital exemption is implemented differently in each member state: Spain has authorised academic CAR-T products (ARI-0001, ARI-0002h) at far lower cost than commercial products, while other countries apply the exemption so narrowly that academic products cannot be used routinely. The 2023 EU pharmaceutical reform proposals address this partly. The proposal is a harmonised hospital exemption with common GMP and pharmacovigilance requirements, mandatory participation in a European outcomes registry, and cross-border recognition so an exempted product from one member state can be used in another.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy, Multiple myeloma.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Regulatory divergence between regions, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.