The Medicines and Healthcare products Regulatory Agency (MHRA) has proposed linking higher fees for selected regulatory services to formal performance guarantees from April 2027. The model would give applicants greater certainty over several high-value timelines and return the performance-related element of the fee increase if MHRA misses a guarantee.
Most statutory fees would rise by 8.93% to reflect expected cost increases. This would apply to 180 fees, representing 62% of the schedule. A further 25 higher-value services would rise by around 27%, including indexation, to fund additional scientific capacity, training and digital infrastructure.
The proposed guarantees include a 90-day first assessment for new active substance applications and a priority pathway with initially ten slots each year. The priority route would cost an additional £100,000 and reduce the overall assessment timetable from 210 to 180 calendar days. Qualifying first-in-human Phase I trials would receive a 14-day initial assessment, while scientific advice would be offered on either a 90-working-day standard timetable or a 45-working-day accelerated route.
Where MHRA misses a guaranteed timeline, it would repay the performance-related part of the targeted fee increase. The underlying fee and 8.93% indexation increase would remain payable. MHRA says applicants value predictable timelines more highly than compensation, but views the rebate as a mechanism for accountability.
The proposal is primarily regulatory, but the charging model has wider access relevance. NICE already charges companies for technology appraisals and highly specialised technology evaluations, while its current methods state that absolute timelines cannot be guaranteed for all stages. There is no published proposal to introduce an MHRA-style premium service for NICE assessments. The consultation nevertheless establishes a UK precedent for linking higher statutory charges to measurable delivery commitments, which may attract attention as government seeks greater predictability across the regulatory-to-reimbursement pathway. (Nice)
Source: Medicines and Healthcare products Regulatory Agency
Link: MHRA consultation on statutory fees 2026
Date: 17 August 2026
