The Medicines and Healthcare products Regulatory Agency (MHRA), in collaboration with the Department of Health and Social Care (DHSC), is conducting a review of the UK’s medicines and medical device regulatory framework, and we are seeking input from stakeholders across the sector, including patients and the public.
The review is a statutory obligation under the Medicines and Medical Devices Act 2021 and is being conducted in accordance with Part 6, Regulation 48 of the Act, which requires the government to assess the operation and impact of the legislation at least once every five years.
We would value your views and experiences on the regulations which are relevant to you or your organisation. Please provide us with unbiased responses and where possible, specific examples.
The findings from the completed survey will inform the Review and a report to be published by the Secretary of State for Health and Social Care. All feedback will be anonymised in the final report.
The deadline for completing the questionnaire is 19th September 2025.
If you have any questions relating to this review and the completion of the survey, please email: Partnerships@mhra.gov.uk, with “MMD Act Review” in the subject line.
About the Review
The focus of the review is the legislation that govern the development, authorisation, supply, and oversight of medicines and medical devices in the UK.
These include:
The objectives of the legislation is to provide a clear framework and expectations for medicines and devices manufacturers and distributors, give the regulator oversight to ensure the requirements are met and action can be taken when they are not, to support supply to patients, and ensure the safety of those products.
The UK medicines and medical devices regulations were originally derived from EU legislation which was transposed into UK law. Over time the regulations have been amended multiple times to reflect changes in scientific practice, public health priorities, and regulatory standards. The Medicines and Medical Devices Act, passed in 2021, provides the primary powers that enable the UK to update and amend the legislation. The purpose of this review is to evaluate whether the legislation is operating as intended now, if it continues to effectively protect public health, and avoids imposing unnecessary or excessive regulatory burdens. The review is also looking at the structure of the legislation and whether restructure or consolidation would make the regulations clearer or easier to implement.
Data Privacy
This Review complies with data protection legislation including the Data Protection Act 2018 (DPA) and the UK General Data Protection Regulation (UK GDPR). Personal data will be kept for no longer than necessary to fulfil our purpose in processing it. Any personal information will be anonymised. Information from this review, including personal information, may be disclosed in accordance with the access to information regimes. These are primarily the Freedom of Information Act 2000 (FOIA), the DPA, the UK GDPR and the Environmental Information Regulations 2004. The MHRA and DHSC will process your personal data in accordance with the DPA and UK GDPR and in most circumstances, this will mean that your personal data will not be disclosed to third parties. The lawful basis for processing personal data is article 6(1)(e) UK GDPR. Further information personal data is handled, including data subject rights, is available in the MHRA privacy notice, and DHSC privacy notice.
