MHRA launches consultation to evaluate the Medicines and Medical Devices Act 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation seeking stakeholder feedback on the operation and impact of medicines and medical devices legislation. The review, mandated under Part 6, Regulation 48 of the Medicines and Medical Devices Act 2021, examines four key regulations: the Human Medicines Regulations 2012, Medical Devices Regulations 2002, Medicines for Human Use (Clinical Trials) Regulations 2004, and Medicines and Medical Devices (Fees) Regulations. The consultation, running until 19 September 2025, aims to assess whether the legislation effectively protects public health without imposing unnecessary regulatory burdens. Findings will inform a report to be published by the Secretary of State for Health and Social Care.