{"entity":{"id":"mhra","kind":"institution","name":"Medicines and Healthcare products Regulatory Agency","aka":["MHRA"],"tldr":"The UK medicines and devices regulator, which since Brexit runs its own approvals, joins Project Orbis and uses international reliance routes to speed cancer drug access.","summary":"Formed in 2003 by merging the Medicines Control Agency and the Medical Devices Agency, the MHRA became the UK's standalone regulator for new medicines after the UK left the EU in 2021. It participates in the FDA-led Project Orbis and the Access Consortium (with Australia, Canada, Singapore and Switzerland), uses the International Recognition Procedure to rely on approvals by trusted regulators, and runs the Innovative Licensing and Access Pathway with NICE and the Scottish Medicines Consortium to align licensing and reimbursement. The MHRA also regulates clinical trials, devices including AI software, and blood and tissue products, and operates the Yellow Card safety scheme.","asOf":"2026-09-09","links":[{"label":"MHRA","url":"https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["radiology-ai-screening","digital-pathology-ai"],"targets":[],"drugs":[],"companies":[],"institutions":["nice","smc","fda-oce","ema","cruk"],"pathways":[],"terms":["accelerated-approval"],"trials":[],"people":["lawrence-tallon"],"bottlenecks":["b-regulatory-fragmentation","b-ai-validation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"London","country":"GB","lat":51.503,"lng":-0.02,"institutionType":"government","website":"https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency","programs":["Project Orbis and Access Consortium","International Recognition Procedure","Innovative Licensing and Access Pathway (with NICE and SMC)","Clinical trials and device regulation"]},"route":"/institutions/mhra/","neighbours":{"technology":[{"id":"radiology-ai-screening","kind":"technology","name":"AI in radiology","route":"/technologies/radiology-ai-screening/"},{"id":"digital-pathology-ai","kind":"technology","name":"Digital pathology & AI","route":"/technologies/digital-pathology-ai/"}],"institution":[{"id":"bfarm","kind":"institution","name":"Bundesinstitut für Arzneimittel und Medizinprodukte","route":"/institutions/bfarm/"},{"id":"cruk","kind":"institution","name":"Cancer Research UK","route":"/institutions/cruk/"},{"id":"ema","kind":"institution","name":"European Medicines Agency","route":"/institutions/ema/"},{"id":"fda-oce","kind":"institution","name":"FDA Oncology Center of Excellence","route":"/institutions/fda-oce/"},{"id":"health-canada","kind":"institution","name":"Health Canada","route":"/institutions/health-canada/"},{"id":"nice","kind":"institution","name":"National Institute for Health and Care Excellence","route":"/institutions/nice/"},{"id":"smc","kind":"institution","name":"Scottish Medicines Consortium","route":"/institutions/smc/"},{"id":"swissmedic","kind":"institution","name":"Swissmedic","route":"/institutions/swissmedic/"},{"id":"tga","kind":"institution","name":"Therapeutic Goods Administration","route":"/institutions/tga/"}],"term":[{"id":"accelerated-approval","kind":"term","name":"Accelerated approval","route":"/terms/accelerated-approval/"},{"id":"ilap","kind":"term","name":"ILAP (Innovative Licensing and Access Pathway)","route":"/terms/ilap/"},{"id":"medicines-medical-devices-act-2021","kind":"term","name":"Medicines and Medical Devices Act 2021","route":"/terms/medicines-medical-devices-act-2021/"},{"id":"uk-data-protection-act","kind":"term","name":"UK Data Protection Act 2018 and health data law","route":"/terms/uk-data-protection-act/"}],"person":[{"id":"lawrence-tallon","kind":"person","name":"Lawrence Tallon","route":"/people/lawrence-tallon/"}],"bottleneck":[{"id":"b-ai-validation","kind":"bottleneck","name":"AI that is built but not validated or deployed","route":"/bottlenecks/b-ai-validation/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}