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.
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.
Shares AI that is built but not validated or deployed, AI in radiology, Digital pathology & AI, Regulatory divergence between regions.
Shares Bundesinstitut für Arzneimittel und Medizinprodukte, European Medicines Agency, Regulatory divergence between regions.
Shares European Medicines Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.
Shares Scottish Medicines Consortium, ILAP (Innovative Licensing and Access Pathway), National Institute for Health and Care Excellence.
Shares European Medicines Agency, FDA Oncology Center of Excellence, Regulatory divergence between regions.
Shares AI that is built but not validated or deployed, AI in radiology, Digital pathology & AI.
Shares Medicines and Medical Devices Act 2021, ILAP (Innovative Licensing and Access Pathway).
Shares Medicines and Medical Devices Act 2021, European Medicines Agency, Regulatory divergence between regions.