The UK Medicines and Healthcare products Regulatory Agency (MHRA) would increase all its statutory fees by 10% as part of wider proposals that represent the agency’s most significant shift in fees and funding in years.
MHRA proposed a 10% increase in all fees after calculating that the rate is in line with the rise in staff costs – which account for half of the agency’s spending – since it last reviewed its rates in 2016. Costs for other outlays, such as IT, laboratories and accommodation, have grown 21% but MHRA notes that it can absorb those increases via cost reduction programs.
The agency also proposes to increase fees above the 10% for 61 services that have seen costs grow even more significantly. MHRA singled out the growing complexity of medical devices and its commitment of additional time to help applicants prepare for assessment as reasons for the larger increases.
For example, the proposed fee for “initial application for designation,” which covers both the Approved Body and Notified Body, would rise from £8,252 ($9,429) to £35,672, a jump of more than 330%. The fee for “follow up audit - special clinical” would increase more than 600%, rising from £2,586 today to £18,583 under the proposals.
MHRA is also considering creating 22 new fees to address changes in the service it offers since the last rate review. For example, agency seeks to create an £1,800 fee for complex amendments. MHRA plans to keep the new fees under review for 12 months to ensure they recover the costs. MHRA is accepting feedback until 23 November.
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