Medicines and Healthcare products Regulatory Agency (MHRA) and its Role and Responsibility

Who is MHRA :

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

When MHRA Formed :

MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was re-branded, with MHRA identity being used solely for the regulatory center within the group. The Agency employs more than 1,300 people.

MHRA is funded by the Department of Health and Social Care for the regulation of medical devices, while the costs of medicines regulation is met through fees from the pharmaceutical industry.

The MHRA works closely with the European regulator, the European Medicines Agency (EMEA), and is recognised as a trusted and independent source of expertise throughout Europe.

The MHRA also collaborates with other international regulators, such as the US Food and Drug Administration (FDA), and UK government agencies involved in healthcare, including the National Patient Safety Agency (NPSA) and the National Institute for Health and Clinical Excellence (NICE).

Responsibility of MHRA :

  • Operate post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.
  • Assessment and authorization of medicinal products for sale and supply in UK.
  • Supervise the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.
  • Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
  • Investigate sales and potential counterfeiting or fake of medicines, and prosecute where necessary.
  • Regulate clinical trials of medicines and medical devices.
  • Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
  • Promote safe use of medicines and devices.
  • Manage the Clinical Practice Research Datalink and the British Pharmacopoeia.
  • Perform inspection or audit in manufacturing and processing site for MHRA regulated product that are sold in UK
  • To perform pre-approval inspection after company submits an application to MHRA to market a new product.
  • To review the Product dossier submitted by the company and to provide the product approval

What MHRA do when quality or safety concerns arise :

  • When a product is suspected or known to be faulty, the MHRA immediately works with manufacturers and wholesalers on the most appropriate and timely action to take.
  • Sometimes this means a product has to be recalled and taken out of the supply chain.
  • By law, manufacturers must report to the MHRA any important defects in both medicines and medical devices.
  • The MHRA is committed to responding promptly and appropriately to concerns that cause threat to the public’s health.
  •  Reports prompt investigations, which can result in the issue of warnings and alerts and MHRA also has the power to prosecute when regulations have been defence.
  • The courts can impose fines or prison sentences when the law has been broken and the Agency can withdraw unlicensed/ illegal products from the market.
  • Warnings (Alerts) can be issued about defective medicines, problems with devices, and side effects associated with medicines and blood and blood products.

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