The MHRA (medicines and Healthcare products Regulatory Agency) is the UK equivalent of the possibly better known FDA (Food and drug administration) is the agency in the US responsible for regulation and investigation of harmful incidents related to medicines and medical devices. This agency was established in 2003 and was created to merge both the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).

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Starting with Adaptive phase 1 studies, with small participant numbers, and moving on all the way through phases two, three and sometimes four with larger cohorts, a drug or treatment may be granted approval by the MHRA when a treatment has been tested sufficiently to prove it is safe and effective for its purpose. The MHRA must licence a drug before it can be prescribed in the UK.

Clinical trials form the basis of ensuring a drug is safe and effective for use in the desired population and more about this can be found at

The MHRA is linked with the Department of Health to ensure it remains in touch with broader healthcare policies. They are also linked to international bodies.

They are responsible for monitoring safety and quality and achieve this with the following;

  • carrying out regular inspections (including clinical trials, manufacture, storage and distribution of medicines, among others),
  • providing published standards for ingredients and quality of medications
  • sampling of a variety of marketed medicines routinely
  • Reviewing new evidence on certain products
  • Commissioning research and providing support for the department of health
  • Ongoing reports regarding updated side effect information (yellow card scheme)
  • Gathering evidence about any illegal manufacture or supply of medications or devices
  • Managing a GP research database
  • Legal enforcement of statutory regulations

The yellow card scheme is an important function for monitoring safety continually of medicines, vaccines, blood products and even herbal and homeopathic remedies. Recently this has also included e cigarettes as they become more accepted as a recommendation for smoking cessation aids. This scheme relies on people reporting anything adverse to obtain as much safety information as possible.

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They also carry out work to ensure accurate and up to date information is available about drugs in the form of the ‘patient information leaflet’ (PIL) which must be enclosed with every pack of medication. The PIL provides information such as the name of the medicine, the strength, the route of administration, posology, warnings and indications. Additionally the guidance suggests that the critical information should be using as large a font as possible.


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