The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001
Sign Up to like & getrecommendations! Published in 2022 at "Bone Marrow Transplantation"
DOI: 10.1038/s41409-021-01463-y
Abstract: In February 2021, the ‘Advanced Therapy Medicinal Product’ (ATMP) ARI-0001 (CART19-BE-01), developed at Hospital Clínic de Barcelona (Spain), received authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) under the ‘hospital exemption’ (HE)… read more here.
Keywords: advanced therapy; therapy medicinal; ari 0001; hospital exemption ... See more keywords