Press release

Fit for purpose MHRA can lead the way for global regulatory reforms

MHRA can place UK at the forefront of a global drive to improve public health according to Triennial Review.

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The government agency that regulates medicines and medical devices to ensure their quality, safety and efficacy can place the UK at the forefront of a global drive to improve public health, according to a new report.

The Medicines and Healthcare products Regulatory Agency (MHRA) is already a leading national regulator at both a pan-European and global level, but can go further and deeper in leading the international community to implement reforms.

That is one of the findings from a ‘Triennial Review’ of the agency, published today (21 July), to ensure it remains fit for purpose and continues to deliver value for money for the UK taxpayer.

MHRA has also been recommended to review its plans for income generation, continue to promote innovation and digital solutions, and increase awareness and engagement of its Yellow Card Scheme, an early warning system to identify potential side-effects and adverse reactions with medicines. People can also use the scheme to report problems with medical devices as well as suspected counterfeit medicines and medical devices.

Crucially the review found that MHRA plays a critical role across each of its regulatory, science and research responsibilities and should continue to operate in its current form.

The agency, in tandem with the Department of Health, its parent Whitehall department, is now working to address and implement a series of improvements.

Chief Executive Dr Ian Hudson, MHRA, said:

We welcome the findings of the Triennial Review

There are some interesting challenges ahead, both domestically and globally, but the review has validated that we are well prepared to enthusiastically tackle them head on.

Indeed, as the review highlights, we have already identified many of the areas where we can work smarter and strive for greater collaboration and efficiency, and we are already actively seeking improvements through our 2015/16 Business Plan.

On behalf of all those who work in the agency, I strongly welcome the clear endorsement in the review of the agency’s fitness for purpose for the critical public health work that we do.

The review took place between November 2014 and May 2015 and was led by a small designated team within the Department of Health team working under the direction of an independent sponsor and project board. The emerging findings were also regularly scrutinised by an external challenge group chaired by a DH non-executive director.

Evidence was gathered through stakeholder interviews and workshops, meetings with sector experts, a public call for feedback and in-depth analysis of published material and in-house documents.

The entire MHRA organisation was in scope, including the Clinical Practice Research Datalink (CPRD) and National Institute for Biological Standards and Control (NIBSC), which merged with the agency in April 2012 and April 2013 respectively.

CPRD provides a resource for conducting observational research and improving the efficiency of interventional research across all areas of health, medicines and devices. NIBSC is recognised as a world leader in assuring the quality of biological medicines through product testing, developing standards and reference materials.

The publication of the Triennial Review ties into MHRA’s 2015/16 business plan and the ongoing delivery of a 5 year corporate strategy.

This year’s key objectives include:

  • progressing work on key EU negotiations and implementation relating to clinical trials, falsified medicines and medical devices
  • closer and stronger collaboration with the Department of Health and partners in the health and care system, ensuring that we are working towards common goals around public health and innovation and growth
  • further developing excellence in science, including developing the capabilities of the National Institute for Biological Standards and Control (NIBSC) to ensure it remains a global leader in standardisation and control of biological medicines
  • improving and enhancing incident and safety reporting systems, principally the Yellow Card Scheme

See the MHRA Triennial Review for more information.


  1. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes NIBSC and CPRD. The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health.

  2. MHRA’s Triennial Review was announced by Life Sciences Minister George Freeman on 30 October 2014 alongside similar reviews for the National Institute for Health and Care Excellence (NICE), the British Pharmacopoeia Commission (BPC) and the Commission on Human Medicines (CHM). The call for evidence opened on 1 December 2014 and ran until 9 January 2015, including stakeholder workshops and interviews.
  3. All Government departments are required to review their non-department public bodies (NDPBs) and executive agencies at least once every three years.

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Published 21 July 2015