We are the regulator of medicines, medical devices and blood components for transfusion in the UK.
We put patients first in everything we do, right across the lifecycle of the products we regulate. We rigorously use science and data to inform our decisions, enable medical innovation and to make sure that medicines and healthcare products available in the UK are safe and effective.
Our responsibilities are to:
- ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy (effectiveness)
- secure safe supply chain for medicines, medical devices and blood components
- promote international standardisation and harmonisation to assure the effectiveness and safety of biological medicines
- educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use
- enable innovation and research and development that is beneficial to public health
- collaborate with partners in the UK and internationally to support our mission to enable the earliest access to safe medicines and medical devices and to protect public health
What and how we regulate
We operate in a statutory framework set by HM Government, working within government and the wider health system to direct overall policy in our regulatory field.
These policies establish our role in securing public health improvements and gives us the powers to deliver against our corporate responsibilities.
We constantly strive for improvement in our field, and when we identify changes that will improve people’s access to safe, quality healthcare products, our recommendations are agreed by the Secretary of State.
Our corporate governance
We are governed by a unitary board of directors with an equal number of executive and non-executive directors, and a non-executive chairperson, supported by three board assurance committees.
The board is responsible for advising on the strategic direction of the agency, ensuring that targets set out in the business plan and agreed with ministers, are met.
The board is not involved in any regulatory decisions affecting medicines or medical devices. These are the responsibility of the chief executive and executive committee (senior leadership team). However, the board members must make declarations of interests to ensure their independence.
Our independent advisory bodies
Advisory Board on the Registration of Homeopathic Products: The advisory board advises on the safety and quality of homeopathic medicines when there’s an application for registration, marketing authorisation or licence of right.
Blood Consultative Committee: The Blood Consultative Committee works with the national executive blood bodies and other stakeholders to develop advice and recommendations on regulatory aspects of blood banks, blood establishments and blood processes.
British Pharmacopoeia: The BP makes an important contribution to the role of the Medicines and Healthcare products Regulatory Agency (MHRA) in protecting public health by providing quality standards for UK pharmaceutical substances and medicinal products.
Clinical Practice Research Datalink (CPRD) Research Data Governance (RDG) Process: Independent scientific and patient advice on research-related requests to access CPRD data via the non-statutory Independent Scientific Advisory Committee was established in 2006, and superseded in June 2021 by the RDG Process comprising Expert Review Committees (ERCs) and the Central Advisory Committee (CAC).
Commission on Human Medicines: The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products.
Devices Expert Advisory Committee: The Devices Expert Advisory Committee (DEAC) replaces the Committee on Safety of Devices and is responsible for providing independent, external expert input and advice on a wide range of aspects relating to medical devices to help the Medicines and Healthcare products Regulatory Agency (MHRA) in the execution of its role in ensuring the safe introduction and management of medical devices.
Herbal Medicines Advisory Committee: The Herbal Medicines Advisory committee advises on the safety and quality of herbal medicines when there’s an application for registration, marketing authorisation or product licence.
The Review Panel: The Review Panel (MHRA) carries out statutory and non-statutory reviews of proposals, decisions and provisional decisions taken by Medicines and Healthcare Products Regulatory Agency.
Our corporate documents