The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is planning to raise its fees for assessing and approving clinical trial applications with effect from 1 April 2008.
Under the regulatory fees proposals set out in consultation letter MLX 344, the cost of assessing a Phase I trial application would increase from £707 to £2,146. For a Phase II or III trial where the product to be evaluated was unknown, the fee would rise from £3,128 to £4,040. Applications for Phase II or III trials with a known product would cost £3,283 compared with £2,607 at present. Fees for a Phase IV trial, additional protocols and cross-referrals respectively would increase from £163 to £252, from £105 to £252, and from £147 to £252.
In addition, there would be new fees of £120 for the accreditation of Phase I trial units and £63 for a certificate of accreditation.
The targeted fee increases are needed to hire 5.5 additional staff to cope with a growing workload of clinical trial applications effectively and without causing delays, the MHRA said. The task of assessing applications has expanded “hugely” in recent years, the agency explained, particularly since the European Union’s Clinical Trials Directive removed the size limits on submissions – previously a maximum 60 pages for chemical and 100 pages for biological products. Applications now generally exceed 400-500 pages and frequently reach 1,000 pages, the MHRA added.
Without extra resources, the agency claims, it will no longer be able to deal with clinical trial applications within its published targets. “We are often told how expensive delay can be in a clinical trials programme, costing many millions of pounds,” MLX 344 states. “Within the overall cost of a clinical trial, the regulatory fees are relatively small. We therefore believe that the proposed fee increases in this area represent the best course of action, in the interests not only of safeguarding health but also of supporting clinical research.”
The consultation letter may be downloaded from the MHRA’s website at www.mhra.gov.uk. The deadline for comments is 9 January 2008.
