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How Hospital Clínic got its own CAR-T authorised in Spain through a route in European law that lets a hospital make an advanced therapy for its own patients, and what stands in the way of others doing the same.
Published as "The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001". The authors, from Hospital Clínic de Barcelona's Advanced Therapies Unit, describe how in February 2021 the advanced therapy medicinal product ARI-0001 (CART19-BE-01), developed at the hospital, received authorisation from the AEMPS under the hospital exemption pathway for patients aged over 25 with relapsed or refractory acute lymphoblastic leukaemia. The hospital exemption, foreseen in the European regulation on advanced therapies, allows access to products prepared on a non-routine basis, to quality standards, for an individual patient, limited to the member state where the product was developed and used in a hospital under a medical practitioner's responsibility. Such products must meet national traceability, pharmacovigilance and quality requirements.
Spain's use of the hospital exemption is a working model for public hospitals making cell therapies at lower cost; the paper is the account of how it was done by the people who did it.
Shares Manel Juan, CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona), Varnimcabtagene autoleucel, Hospital Clínic de Barcelona / IDIBAPS.
Shares Manel Juan, Point-of-care and decentralised cell manufacturing, Hospital Clínic de Barcelona / IDIBAPS, CAR-T cell therapy.
Shares Manel Juan, Point-of-care and decentralised cell manufacturing, Hospital Clínic de Barcelona / IDIBAPS, CAR-T cell therapy.
Shares Varnimcabtagene autoleucel, Point-of-care and decentralised cell manufacturing, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares Varnimcabtagene autoleucel, Point-of-care and decentralised cell manufacturing, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
Shares CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona), Hospital Clínic de Barcelona / IDIBAPS.
Shares CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona), Hospital Clínic de Barcelona / IDIBAPS.
Shares Point-of-care and decentralised cell manufacturing, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
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