{"id":59463,"date":"2015-07-21T16:48:23","date_gmt":"2015-07-21T16:48:23","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=5f8cb5c29e586368d7a92d9a2ebe261c"},"modified":"2015-07-21T16:48:23","modified_gmt":"2015-07-21T16:48:23","slug":"press-release-fit-for-purpose-mhra-can-lead-the-way-for-global-regulatory-reforms","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=59463","title":{"rendered":"Press release: Fit for purpose MHRA can lead the way for global regulatory reforms"},"content":{"rendered":"
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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. <\/p>\n

The Medicines and Healthcare products Regulatory Agency (MHRA<\/abbr>) 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. <\/p>\n

That is one of the findings from a \u2018Triennial Review\u2019 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. <\/p>\n

MHRA<\/abbr> 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. <\/p>\n

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

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

Chief Executive Dr Ian Hudson, MHRA<\/abbr>, said:<\/p>\n

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We welcome the findings of the Triennial Review<\/p>\n

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.<\/p>\n

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.<\/p>\n

On behalf of all those who work in the agency, I strongly welcome the clear endorsement in the review of the agency\u2019s fitness for purpose for the critical public health work that we do.<\/p>\n<\/blockquote>\n

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. <\/p>\n

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. <\/p>\n

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

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

The publication of the Triennial Review ties into MHRA<\/abbr>\u2019s 2015\/16 business plan and the ongoing delivery of a 5 year corporate strategy. <\/p>\n

This year\u2019s key objectives include: <\/p>\n