The Medicines and Healthcare Products Regulatory Agency (MHRA) 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.
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 globalized industries; achieving excellence—a well run, efficient and effective organization.
“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,” said Sir Kent Woods, chief executive of MHRA.
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 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 program which will aim to cut red tape and help industry achieve regulatory compliance.