MHRA sets out five-year corporate plan
National Institute for Biological Standards and Control (NIBSC) becomes part of MHRA this month
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) aims to be a leading regulator on the world stage in supporting science and research as part of its new five-year corporate plan, which has been developed using responses from a public consultation launched last December. It also aims to continue to protect and improve the health of the nation through the effective regulation of medical products.
The five key themes on which the corporate plan 2013–18 concentrates are:
- The role of regulation and the regulator
- Bringing innovation safely to market
- Strengthening surveillance
- Safe products and secure supply in globalised industries
- Achieving excellence through a well run, efficient and effective organisation
Some big changes to the MHRA will kick-start the plan as the National Institute for Biological Standards and Control (NISBC) becomes part of the organisation this month.
The period of the corporate plan will also see the further development of the Clinical Practice Research Datalink (CPRD), a secure health research service launched by the MHRA in March 2012.
Professor Sir Gordon Duff, Chairman of the MHRA, said the addition of the NISBC would reinforce the MHRA’s capabilities in regulating the new generation of biological products and its role in an area of science that is of central importance to the wellbeing of the nation.
He added that the CPRD would provide a ‘world-class link into the unique healthcare datasets of the NHS, offering unprecedented opportunities to link regulation to clinical practice in the real world’.
Our corporate plan sets out our key aim of protecting and enhancing the health of millions of people through better regulation of medicines and medical devices
The corporate plan reflects the MHRA’s desire to lead regulatory matters globally and bring new innovative medicines and products safely to market. The MHRA’s new online Innovation Office recently launched, providing advice to manufacturers on the regulatory process.
This new plan will also help the MHRA to develop strategic processes where change is needed to improve core regulatory work including implementing new requirements to strengthen the surveillance and vigilance systems for medicines.
The corporate plan feeds into annual business plans setting out specific targets and activities that will contribute to the delivery of the corporate plan. One area of the 2013-14 business plan is major negotiations of new legislation relating to clinical trials and device regulation.
As part of its commitment to promoting growth, the MHRA has also devised a regulatory excellence programme, which will aim to cut red tape and help industry achieve regulatory compliance.
The organisation will continue to have a ‘gatekeeper function’, but will not have a role in evaluating the cost-effectiveness of medicines or medical devices.
The MHRA will strengthen its surveillance and vigilance systems for medicines by using the benefits of CPRD data and will partner other regulators to support uniform global quality standards, especially in the area of biologics and to prevent counterfeit and substandard products entering the legitimate supply chain.
The MHRA has new top management and alongside Sir Gordon Duff will appoint a new Chief Executive in the first half of this year to succeed Sir Kent Woods, who is retiring.
Woods said: ‘Our corporate plan sets out our key aim of protecting and enhancing the health of millions of people through better regulation of medicines and medical devices and promoting innovation.
‘We have an exciting five years ahead with the introduction of the National Institute for Biological Standards and Control (NISBC) to the MHRA family this year and we are focused on achieving our aim of being a world leader in supporting science and research.’