The Medicines and Healthcare products Regulatory Agency (MHRA) has published its business plan for 2014/15, which sets out how the Agency intends to develop in response to the changing business environment in which it is now operating.

Over the coming years, the Agency says it will be reducing the size of its regulatory and corporate divisions. It will also be growing the businesses of the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD), and maximising the benefits these centres can bring.

During 2014/15, the MHRA will be looking for new income streams, developing new products and services and promoting them to existing and potential customers, at the same time maintaining its focus on public health and “science-based, impartial decision-making.”

“We will prioritise our activities and focus resources on the core activities that we must undertake, and the other activities that have the greatest impact or highest value. We will also identify non-value-added work that we should stop doing, and continue to improve our productivity and increase our efficiency across the organisation, simplifying processes where possible,” it says.

The challenges and changes for MHRA identified in the report include:

- the global nature of medicine and device manufacturing, with new producer countries and markets emerging all the time. Fewer medicines are being licensing, and there is a dramatic increase in the development of new medical technologies and products, including biological and biosimilar medicines;

- the evolving European regulatory model. For medicines, work patterns are changing and there is a continuing shift from national to European Union (EU) licensing;

- changing expectations from patients and the public, in line with general shifts in society and aided by the power of social media. “Where at one time the view of the regulator was widely accepted, it is now often subject to challenge and greater transparency is expected,” it says; and

- radical changes in the UK health and care system, with new organisations and an increased emphasis on partnership and joined-up working.

And while there are signs that the UK economy is coming out of recession, the Agency’s financial position is getting more challenging. “There will be continuing budgetary pressure across government and an expectation on us to support growth, the life sciences and innovation,” it says.

For NIBSC, the primary objective during 2014/15 will be to “continue to grow and invest to remain the global leader in biological medicines, and to maintain our global leadership position in biological standardisation.”

And the Agency intends that NIBSC’s recently-established Advanced Therapies Division should become a major international hub for scientific expertise in cell and gene therapies, identifying and meeting needs for standardisation within the field, ensuring an internal capability to analyse and test cell and gene therapy products in the event of incidents and emergencies.

And CPRD will seek to establish a secure e-health research data service “offering unparalleled access to real-world health data and supporting all types of data research and clinical trials. This will enable CPRD to achieve its public health and growth objectives as a world-class link into the unique healthcare datasets of the NHS,” says the MHRA.