{"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":[],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["ema"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"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":{"institution":[{"id":"ema","kind":"institution","name":"European Medicines Agency","route":"/institutions/ema/"}],"section":[{"id":"f-radiochemistry","kind":"section","name":"Radiochemistry & manufacturing","route":"/fronts/f-radiochemistry/"},{"id":"f-regulation-reimbursement","kind":"section","name":"Regulation & reimbursement","route":"/fronts/f-regulation-reimbursement/"}]}}