{"entity":{"id":"aemps","kind":"institution","name":"Spanish Agency of Medicines and Medical Devices (AEMPS)","aka":["AEMPS","Agencia Española de Medicamentos y Productos Sanitarios"],"tldr":"Spain's medicines regulator. It authorises clinical trials and the medicines not approved centrally in Europe, lets doctors obtain unapproved medicines for individual patients, and in 2021 approved a CAR-T made by a Spanish public hospital.","summary":"The AEMPS is the state agency that authorises and supervises medicines and medical devices in Spain. Most new cancer medicines are authorised for the whole European Union by the European Commission after an opinion of the European Medicines Agency's CHMP, so for them the AEMPS's national role is to assign the national code, take part in the European assessment, and supervise use afterwards.\n\nIts own activity report for 2025, published on 2 June 2026, records 962 clinical trials of medicines authorised in humans, which it describes as the highest number in the European Union for another year, 1,354 human medicines authorised and 101,150 requests for foreign medicines received and assessed, 98% of them resolved. In January 2026 it reported that 378 of the 962 trials were in oncology, close to 40% of the total, and that phase I and I/II trials had risen from 156 (19% of those authorised) in 2015 to 244 (25%) in 2025.\n\nUnder Real Decreto 1015/2009 it authorises compassionate use of investigational medicines for individual patients, access to medicines authorised abroad but not in Spain, and sets the rules for off-label use. In February 2021 it authorised the Hospital Clínic CAR-T ARI-0001 under the hospital exemption for adults over 25 with relapsed or refractory acute lymphoblastic leukaemia. Under Real Decreto 415/2026 it hosts the new office for the evaluation of medicines in Spain's health technology assessment system.","asOf":"2026-11-03","links":[{"label":"AEMPS: Memoria de Actividades 2025 announcement (2 June 2026)","url":"https://www.aemps.gob.es/informa/la-aemps-presenta-los-principales-hitos-de-2025-en-su-memoria-de-actividades/"},{"label":"AEMPS: España consolida su liderazgo europeo en investigación clínica (12 January 2026)","url":"https://www.aemps.gob.es/informa/espana-consolida-su-liderazgo-europeo-en-investigacion-clinica/"},{"label":"AEMPS: authorisation of ARI-0001 (10 February 2021)","url":"https://www.aemps.gob.es/informa/la-aemps-autoriza-el-car-t-ari-0001-del-hospital-clinic-para-pacientes-con-leucemia-linfoblastica-aguda/"},{"label":"Real Decreto 1015/2009, medicines in special situations (BOE)","url":"https://www.boe.es/buscar/act.php?id=BOE-A-2009-12002"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["car-t"],"targets":[],"drugs":["varnimcabtagene-autoleucel"],"companies":[],"institutions":["hospital-clinic-barcelona"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-trias-hospital-exemption-ari-0001-bmt-2022"],"journals":[],"dependsOn":[],"notes":[],"city":"Madrid","country":"ES","lat":40.448,"lng":-3.597,"institutionType":"government","website":"https://www.aemps.gob.es","programs":["Clinical trial authorisation (REec registry)","Medicines in special situations (RD 1015/2009)","Therapeutic positioning reports (IPT, REvalMed SNS)","Office for the evaluation of medicines (RD 415/2026)","Hospital exemption for advanced therapies"]},"route":"/institutions/aemps/","neighbours":{"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"drug":[{"id":"varnimcabtagene-autoleucel","kind":"drug","name":"Varnimcabtagene autoleucel","route":"/drugs/varnimcabtagene-autoleucel/"}],"institution":[{"id":"hospital-clinic-barcelona","kind":"institution","name":"Hospital Clínic de Barcelona / IDIBAPS","route":"/institutions/hospital-clinic-barcelona/"}],"paper":[{"id":"paper-trias-hospital-exemption-ari-0001-bmt-2022","kind":"paper","name":"The hospital exemption pathway for advanced therapies and the case of the CAR-T ARI-0001","route":"/key-papers/paper-trias-hospital-exemption-ari-0001-bmt-2022/"}]}}