Medicines and Medical Devices Act 2021

United Kingdom, statute. The Medicines and Medical Devices Act 2021 received Royal Assent on 11 February 2021. Before Brexit the UK's medicines rules, mainly the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004, had been made under the European Communities Act 1972, which was repealed; the Act provides the replacement power. Primary text: legislation.gov.uk.

What it does: it lets the Secretary of State amend the law on human medicines, veterinary medicines, clinical trials and medical devices by regulations, having regard to safety, availability and the attractiveness of the UK as a place to develop and supply medicines, with consultation and parliamentary scrutiny; it created the Commissioner for Patient Safety recommended by the Cumberlege review into pelvic mesh, valproate and Primodos; and it strengthened enforcement and information sharing for medical devices. Regulations made under it include the International Recognition Procedure of 2024 and the 2025 reform of clinical trial regulations, which cut approval timelines and embedded combined regulatory and ethics review.

The arguments: peers and the House of Lords committees criticised the breadth of the delegated powers and won amendments requiring the government to prioritise safety; supporters said flexibility was needed to keep pace with the EU and the FDA. The Act is the legal foundation of every post-Brexit MHRA scheme that affects cancer medicines, from ILAP to the recognition of Project Orbis and FDA approvals.