The Medicines and Healthcare Products Regulatory Agency (MHRA) today announced its aim to be a leading regulator on the world stage in supporting science and research as part of its new five-year corporate plan. Alongside protecting and improving the health of millions of people everyday through effective regulation of medical products.
The plan has been developed using responses from stakeholders following a recent public consultation that was launched in December 2012. The five key themes the corporate plan concentrates on 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 – a well run, efficient and effective organisation.
In April 2013, the MHRA family will expand with the transfer of the National Institute for Biological Standards and Control (NISBC) from the Health Protection Agency. This means the remit of the MHRA continues to grow and NIBSC will be an important part of the MHRA family alongside the Clinical Practice Research Datalink (CPRD), a world-class secure health research service launched in March 2012.
This 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.
MHRA Chief Executive, Professor Sir Kent 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.”
Notes to Editor
1. Corporate Plan 2013-2018 (Link to PDF)
2. Business Plan 2013-2014 (Link to PDF)
3. Regulatory Excellence Programme 2013-14 and beyond (Link to PDF)
4. Professor Sir Kent Woods explaining the new Corporate Plan: Corporate plan video (link to YouTube)
5. The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.