Medicines and Healthcare products Regulatory Agency

UK government agency responsible for regulating medicines and medical devices

The logo of the Medicines and Healthcare products Regulatory Agency

The Medicines and Healthcare products Regulatory Agency (MHRA) is a UK government agency responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA is an executive agency of the Department of Health and Social Care.

History

The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). This consolidation aimed to streamline the regulation of medicines and medical devices in the UK.

Responsibilities

The MHRA is responsible for:

• Regulating medicines, medical devices, and blood components for transfusion in the UK.
• Ensuring that medicines and medical devices meet applicable standards of safety, quality, and efficacy.
• Overseeing the licensing of medicines and the approval of clinical trials.
• Monitoring the safety of medicines and devices through a system of pharmacovigilance.
• Conducting inspections and enforcement actions to ensure compliance with regulations.

Structure

The MHRA is structured into several divisions, each focusing on different aspects of regulation:

• The Licensing Division, which handles the approval of new medicines and clinical trials.
• The Devices Division, which oversees the regulation of medical devices.
• The Vigilance and Risk Management of Medicines Division, responsible for monitoring the safety of medicines.
• The Inspectorate and Enforcement Division, which conducts inspections and enforces compliance.

Key Functions

Licensing

The MHRA grants licenses for medicines to be marketed in the UK. This process involves a thorough assessment of the medicine's safety, quality, and efficacy.

Pharmacovigilance

The agency operates a pharmacovigilance system to monitor the safety of medicines once they are on the market. This includes the collection and analysis of adverse drug reaction reports.

Medical Devices Regulation

The MHRA regulates medical devices to ensure they meet safety and performance standards. This includes pre-market assessment and post-market surveillance.

Inspections and Enforcement

The agency conducts inspections of manufacturers and distributors to ensure compliance with regulations. It also has the authority to take enforcement actions against non-compliant entities.

Related pages

• Department of Health and Social Care
• Medicines Control Agency
• Medical Devices Agency
• Pharmacovigilance