The agency said it is “taking steps to ensure our financial sustainability” and the first round of lay-offs will begin this year.
The MHRA did not share its targets for the headcount reduction, or whether the lay-offs will affect inspection and review roles.
A spokesperson told us the redundancies are part of “efficiency savings from divisions across the agency” and “there will not be any impact on the quality of our services and the agency continues to remain in a secure financial position.”
Data, pathways and biologics
In a business plan released yesterday, the organisation announced the rest of its plans for 2015-2016: implementing new rules on clinical trial transparency and fake medicines, as well as supporting the Accelerated Access pathway for medicines and the biologics industry.
It will also expand the Clinical Practice Research Datalink (CPRD), a database for anonymised clinical data from NHS (UK National Health Service) patients that can be used in drug research.
MHRA shared its strategy to advance the country’s biologics industry, encouraging a partnership between the UK Bio Industry Association (BIA) and SMEs on technical advice for developing new biologics. It will work with the National Institute for Biological Standards and Control (NIBSC), the body for regulating biopharmaceutical quality, to write reference materials for developers of personalised medicines.
MHRA said creating an Accelerated Access Review will be “an absolute priority” over the next year.
Formerly known as the Innovative Medicines and Medical Technology Review, the pathway was launched last November and is going through public consultations.
The finished version will set out tactics for government departments, MHRA, and NICE (National Institute for Health and Care Excellence) to speed cost-effective medicines to market. Another goal of the Review is to attract “innovators” to conduct their pharmaceutical R&D in the UK, said MHRA.
The Review will incorporate “patient perspectives on unmet needs, as well as important measures to assess innovations, guiding their development and determining their value,” said the agency.
‘Promising’ meds designation
MHRA said it will support pharmaceutical innovation in other areas over the next year by developing its programmes for Adaptive Pathways, Advanced Manufacturing, an Early Access to Medicines Scheme (EAMS), and the Promising Innovative Medicine designation – applied when early-stage clinical data suggests a drug is likely to bring “significant benefit” to patients with serious illnesses.
The agency said it will work on regulatory issues with the Manufacturing Industry Partnership (MMIP) under the Ministerial Industry Strategy Group (MISG), both set up last year as part of the UK Prime Minister’s Life Sciences strategy.