“Our vision of success is to enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research,” stated the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom as it unveiled its 2013–2018 corporate plan on 11 April. The agency announced its aims to be a leading regulator on the world stage in supporting science and research as part of its five-year corporate plan, which was developed using responses from a public consultation launched last December.
Professor Sir Gordon Duff, chairman of the MHRA, said in his foreword that the plan “sets out our ambition to seize the opportunities from our enlarged role to build a world-class organisation in all aspects of the work we do.”
“We have an unusual, if not unique, set of activities encompassing regulation, standards, research and information; we work at a critical juncture between science, industry and clinical practice.” Duff stressed that it is the regulator’s duty and responsibility to carefully assess the relative benefits and risks of products and determine which will enter and remain on the market.
The corporate plan sets out key challenges and opportunities for the next five years, key objective and activities as well as the outcomes expected. The themes revolve around the role of regulation and the regulator, bringing innovation to market, strengthening surveillance, safe medicines and devices with secure supply in globalised industries and achieving excellence through a well-run, efficient and effective organisation.
A major change will be the expansion of the MHRA, whereby the National Institute of Biological Standards and Control (NISBC) will become part of the agency. There will also be further development of the Clinical Practice Research Datalink (CRPD), which is a world-class secure health research service launched by the MHRA in March 2012.
According to Duff, the addition of the NISBC would reinforce the agency’s capabilities in regulating the new generation of biological products, an area that is of central importance to the nation’s wellbeing. CPRD, on the other hand, would provide a link to the unique healthcare datasets of the National Health Service (NHS) and thereby, offer unprecedented opportunities to link regulation to real-world clinical practice.
Apart from establishing itself as a global leader in regulatory matters, the MHRA is also committed to bringing new innovative medicines and products safely to the market. As Duff rightly pointed out “acting in the best interests of individual and public health also means supporting innovation in the development of useful new medicines and devices.” The agency recently launched a new online Innovation Office that provides advice on regulatory processes to manufacturers.
In addition, the MHRA’s new corporate plan will focus on developing strategic processes where change is needed to improve core regulatory work, such as by implementing new requirements to strengthen surveillance and vigilance systems for medicines. Besides using the benefits of CRPD to strengthen its surveillance and vigilance systems, the MHRA will also join forces with other regulators to support uniform global quality standards, especially in preventing counterfeits and substandard products from entering the legitimate supply chain.
Specific targets and activities that will contribute to the delivery of the corporate plan have also been set out. An important area is the negotiations on the new legislation relating to clinical trials and device regulation. There is an increasing role for regulation to help inform and influence individual clinical decisions; and whilst the MHRA will hold a ‘gatekeeper function,’ it will not be involved in evaluating the cost effectiveness of medicines or medical devices.
To demonstrate its commitment to promoting growth, the MHRA has devised a regulatory excellence program that aims to cut red tape and help the industry achieve regulatory compliance. The agency’s objectives, amongst others, are to influence thinking and regulation in the EU as well as globally to achieve a convergence of standards, to ensure that EU laws are effectively enforced and to explore, in the context of government interest in adaptive licensing, how to redraw the boundary between pre-and post-market entry regulation to enable earlier patient access to beneficial innovative products whilst managing associated risks.
“We are focused on achieving our aim of being a world leader in supporting science and research,” said MHRA chief executive, Professor Sir Kent Woods. “We have an exciting five years ahead.”