MHRA Fee Proposals: What Changes in 2027?

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on a substantial update to its statutory fees, with the proposed changes intended to take effect from 1 April 2027.

While most fees would rise by indexation, the package goes much further than a routine annual uplift. Beyond these routine annual increases, the most notable amendments include targeted increases for higher-value services, major adjustments where current charges no longer reflect delivery costs, new service performance guarantees and rebates, changes to scientific advice applications, and enhanced support for eligible small and medium-sized enterprises (SMEs).

For pharmaceutical, biotechnology and medical device companies, the key message is clear: this is both a consultation opportunity and a planning issue.

Some organisations may face materially higher regulatory costs, while others may benefit from clearer timelines, new service routes or targeted SME support.

Companies have been given a valuable opportunity to allow them to assess the proposals against their 2027 regulatory plans now, identify where activity could be affected, and consider whether resourcing or submission timing needs to change ahead of 1 April.

Why is the MHRA proposing these changes?

As well as aiming to recover the expected cost of ongoing services, the increases would enable MHRA investment in specialist staff training and improvement of systems, all of which are intended to support the reliability and predictability of delivery of important services, moving forward into the future.

The consultation is therefore framed around these two linked objectives: maintaining cost recovery and funding higher-value services.

The MHRA acknowledges the importance of speed, reliability and predictability, whilst maintaining safety and quality, and the proposed package aims to translate the additional funding into stronger capability, clearer standards and, for selected routes, guaranteed timelines.

Overall, the proposals are intended to enhance the UK’s position as an attractive and competitive environment for life sciences companies to operate, invest, and innovate.

Most fees would increase by 8.93%

The majority of fees would rise by indexation only (8.93%). These services are not being changed in nature; the uplift is intended to keep charges aligned with delivery costs.

Higher-value services would see targeted increases

Certain other fees would increase by approximately 27%. These are wide-ranging and include selected clinical trials, marketing authorisation, pharmacovigilance, labelling, export certificates, and variation activities. The MHRA links the uplift to investment in scientific assessor capacity, training, capability building and digital infrastructure, with the aim of delivering more reliable, predictable and timely services.

Some fee adjustments are much larger

Significant financial impact will also be seen by the proposed adjustments to a number of fees that the MHRA says no longer reflect the cost of providing the service. The activities impacted by these adjustments are wide-ranging: 73 fees fall into this category, and the scale of change varies considerably. Some examples are shown below:

• Certain Type II variation fees would increase from £419 to £1,676, a 300% rise.
• A Marketing Authorisation Application for a complex International Recognition Type A procedure would increase from £13,983 to £27,966, a 100% rise.
• The fee for a regulatory advice meeting for medical devices would increase from £987 to £2,245, a 127% rise.

These examples show why companies should review the proposed fee schedule details, rather than relying on the headline indexation figure. The impact will depend on product type, submission route and the volume and timing of planned lifecycle activities.

Guaranteed delivery timelines

The proposals also introduce performance guarantees for selected high-value, time-sensitive services. There are a number proposed, including the introduction of a new “Priority Pathway”, which is intended to provide a shorter review timeline for New Active Substances, initially with only up to 10 available slots per year, and incurring an additional £100,000 fee.

The proposed performance guarantees would also cover a 90-day first assessment for New Active Substance licensing applications, a 14-day initial assessment for Phase I first-in-human clinical trial applications, and certain scientific advice applications.

Where a guaranteed timeline applies, the MHRA proposes a rebate mechanism. If the agency misses the guaranteed timeline, the performance-related element of the targeted increase would be returned, while the original fee and indexation element would remain payable. The detailed design will be developed after consultation, making stakeholder feedback particularly valuable.

Improvements for Scientific Advice applications

Scientific advice is another important area proposed for change. The MHRA proposes tiered options: a 45-working-day accelerated route for eligible high- and medium-complexity advice, a 90-working-day standard route, clearer service standards and rebates for the accelerated route. It is also considering a route for non-scientific regulatory questions.

The proposed fees reflect the greater differentiation in response time. For example, high-complexity advice would increase from £17,516 to £22,555 for the standard 90-day service, while the proposed 45-day fast-track fee would be £45,111. Companies should consider the urgency of advice carefully when planning budgets and timelines.

Proposed support for eligible SMEs

Recognising that higher fees and regulatory delays may affect smaller organisations more heavily, the MHRA proposes enhanced financial support for eligible SMEs. The support is proposed to operate via a waiver or voucher mechanism, helping eligible SMEs at key stages throughout development, including scientific advice and clinical trials; the details have not yet been finalised.

What should companies do now?

• There is time to thoroughly review the proposals and consider responding to the consultation. Responses can address the overall approach and comment on specific fee changes and the potential impact on market activity, innovation or production. The consultation runs until 25 September 2026.
• Map planned UK regulatory activity for 2027 and assess timelines and potential budget impact.
• Compare current and proposed charges and build scenario-based budgets for activities expected on or after 1 April 2027.
• Identify activities with significant fee increases and assess whether timing, grouping, sequencing or resourcing assumptions could be revised.
• Evaluate whether the proposed enhanced routes could offer value for time-critical programmes.

Changes in fees alone don’t drive a decision to bring activities forward; this is based on regulatory readiness and broader company strategy, but having advance notification of these changes provides an opportunity to evaluate UK regulatory activities and timelines strategically.

Key source

Read the MHRA consultation on statutory fees (2026) and submit a response through the consultation survey by 25 September 2026.

Conclusion

The MHRA’s 2026 consultation represents a wide-ranging proposed overhaul of statutory fees and selected regulatory services. Most fees would rise by 8.93%, but targeted and cost-based adjustments mean that some activities could become considerably more expensive. At the same time, the package proposes guaranteed timelines or rebates for selected services, a restructured scientific advice offering, and enhanced SME support.

For life sciences companies, the period before 1 April 2027 should be treated as an active planning window. DLRC can help organisations interpret the proposals, assess the impact on individual portfolios, plan submission and lifecycle activity, prepare consultation input, and provide flexible regulatory resource where programmes need to be progressed ahead of or around implementation. Early review will help companies avoid budget surprises and align regulatory activity with the right expertise, capacity and timing. Contact our experts at hello@dlrcgroup.com.