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Health watchdogs and authorities

Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC), and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.

Aims

The MHRA aims:

  • To protect public health through regulation, including the development of benefit and risk profiles for medicines and devices.
  • To promote public health by helping people to understand the risks and benefits of the products they use.
  • To improve public health by facilitating the development of products that will benefit people.

Key activities:

  • To assess the safety, quality and efficacy of medicines, including to authorise their sale or supply in the UK for human use.
  • To operate rigorous surveillance and inspection systems for the investigation of adverse reactions to medicines (the Yellow Card Scheme) and to adverse incidents involving medical devices, taking any necessary action to safeguard public health.
  • To operate 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.
  • To regulate clinical trials of medicines and medical devices.
  • To monitor and ensure compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary.
  • To promote good practice in the safe use of medicines and medical devices.
  • To provide the public and professions with authoritative information to enable informed dialogue on treatment choices
     

Work with other organisations

The MHRA also works closely with other health bodies including:

National Patient Safety Agency (NPSA)
The NPSA aims to improve the safety of patient care by informing, supporting and influencing healthcare organisations and individuals working in the health sector.

Care Quality Commission (CQC)
The CQC regulates all health and adult social care services in England, whether they’re provided by the NHS, local authorities, private companies or voluntary organisations. It also protects the interests of people detained under the Mental Health Act.

Health Protection Agency (HPA)
The HPA supports and advises the NHS, local authorities, emergency services, the Department of Health and others in its aim of improving public health.

National Institute for Clinical Excellence (NICE)
NICE is an independent organisation that provides national guidance on the promotion of good health and the prevention of ill health.

Others

 

Comments

Page last reviewed: 07/02/2014

Next review due: 07/02/2016

Reporting an adverse effect

The Yellow Card Scheme is a special reporting system for possible adverse effects of medicines. If the healthcare professional treating you thinks a medicine may have caused a potentially concerning effect, they will fill in a report and send it to the MHRA.

You can also use the Yellow Card Scheme yourself, or on behalf of a child or adult in your care, by:

- calling 0808 100 3352 to report an adverse effect over the phone

- asking your pharmacist for a Yellow Card form you can send in the post

- logging onto the Yellow Card Scheme website to report an adverse effect online

Side effects: the Yellow Card Scheme

All medicines can cause side effects. Some may not yet be known, so that's why it's important for people to report to the Yellow Card Scheme.

Media last reviewed: 30/09/2013

Next review due: 30/09/2015

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