Medicines and Healthcare Products Regulatory Agency

(asked on 25th April 2024) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps is she taking to review the decisions of the Medicines and Healthcare products Regulatory Agency.


Answered by
Andrew Stephenson Portrait
Andrew Stephenson
Minister of State (Department of Health and Social Care)
This question was answered on 30th April 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) performs the functions of my Rt hon. Friend, the Secretary of State for Health and Social Care, under United Kingdom legislation, relating to the regulation of medicines, medical devices, and blood products for transfusion. The MHRA also performs the functions of my Rt hon. Friend, the Secretary of State for Health and Social Care in relation to the standardisation and control of biological medicines including vaccines, blood products, and other substances which cannot be characterised chemically, and which require special testing measures to ensure their safety and efficacy.

My Rt hon. Friend, the Secretary of State for Health and Social Care has ministerial responsibility for, and oversight of, the MHRA’s delivery and performance. The MHRA seeks ministerial agreement for policy and legislative framework changes. Ministers are not involved in individual decisions made by the MHRA. The MHRA is held to account through regular established mechanisms including quarterly and annual accountability reviews. A framework agreement between the Department and the MHRA also sets out the governance structure within which both parties operate, with further information available at the following link:

https://www.gov.uk/government/publications/dh-and-mhra-framework-agreement/framework-agreement-between-dhsc-and-the-medicines-and-healthcare-products-regulatory-agency

The MHRA also publishes performance figures each month, as well as its annual report and accounts, and the minutes of the latest Annual Accountability Review with the MHRA is available at the following link:

https://www.gov.uk/government/publications/annual-accountability-review-mhra/annual-accountability-review-minutes-2022-to-2023-3-july-2023

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