Medicines and Healthcare products Regulatory Agency (MHRA)

The Medicines and Healthcare products Regulatory Agency (MHRA) was set up in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.

Mission

The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.
Values
In pursuing our mission we will strive to act with:

• integrity
• openness
• courtesy
• responsiveness
• timeliness
• professionalism
• impartiality
• consistency.

Aims

Our aims are:

• Protecting public health through regulation, with acceptable benefit-risk profiles for medicines and devices.
• Promoting public health by helping people who use these products to understand their risks and benefits.
• Improving public health by encouraging and facilitating developments in products that will benefit people.

Objectives

Our strategic objectives are to:

• safeguard public health through our primary role in ensuring that the products we regulate meet required standards, that they work and are acceptably safe
• carry out our communication role through the provision of accurate, timely and authoritative information to healthcare professionals, patients and the public
• support research, ensuring through the application of Better Regulation principles that regulation does not stifle innovation
• influence the shape of the future regulatory framework through use of our effective European and International relationships
• run an organisation with a skilled and equipped workforce that is fit for the future.

Our activities

Our main activities are:

• assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the UK for human use
• overseeing the UK Notified Bodies that audit medical device manufacturers
• operating post-marketing surveillance and other systems for reporting, investigating and monitoring adverse reactions to medicines and adverse incidents involving medical devices and taking any necessary action to safeguard public health, for example through safety warnings, removing or restricting the availability of products or improving designs
• operating a proactive compliance programme for medical devices
• operating a quality surveillance system to sample and test medicines and to address quality defects, monitoring the safety and quality of imported unlicensed medicines and investigating Internet sales and potential counterfeiting of medicines
• regulating clinical trials of medicines and medical devices
• monitoring and ensuring compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary;
• promoting good practice in the safe use of medicines and medical devices
• managing the General Practice Research Database (GPRD) and the British Pharmacopoeia (BP) and contributing to the development of performance standards for medical devices; offering scientific, technical and regulatory advice on medicines and medical devices
• providing the public and professions with authoritative information to enable informed dialogue on treatment choices. These activities are supported by our ten divisions who are also responsible for: information management
• providing executive support services; human resources; and finance.