MHRA Consults on Fee Increases, Service Standards, and SME Support for 2027
The MHRA proposes statutory fee updates from April 2027, driven by cost recovery and service improvement, impacting product authorisation, scientific advice, and medical device post-market surveillance. New service standards and SME support are also on the table.
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London, United Kingdom — 17 August 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on proposed changes to its statutory fees, scheduled to take effect from 1 April 2027. The proposals aim to ensure full cost recovery for regulatory services while funding improvements in reliability, predictability, and timeliness across its operations. This initiative directly impacts all supplement and medical device manufacturers and brand owners operating within the UK market.
Key proposals include increasing most existing fees in line with inflation through indexation. Additionally, the MHRA intends to implement targeted increases for a small number of 'higher-value services' and a phased update to medical device post-market surveillance fees. These adjustments are designed to align fees with the agency's operational costs and investment priorities. While specific percentage increases are not detailed in the summary, the focus on cost recovery suggests non-negligible increments.
Crucially, the consultation also outlines plans for enhanced service standards, including guaranteed timelines and rebates for selected services. This aims to improve the predictability of regulatory processes, a longstanding pain point for the industry. Simultaneously, the MHRA proposes enhanced support mechanisms specifically for eligible small and medium-sized enterprises (SMEs), potentially offering relief or tailored pathways for smaller market players. Improvements to the scientific advice service are also targeted, which could streamline product development and claims substantiation processes.
What this means for United Kingdom
UK supplement manufacturers and brand owners face increased regulatory compliance costs, with most statutory fees indexed upwards from April 2027. Businesses relying on 'higher-value services' or involved in medical devices will see specific fee hikes, necessitating margin re-evaluation and potentially reformulation windows. The introduction of guaranteed service timelines offers a competitive edge for companies optimising their submission processes, reducing market entry delays, and allowing more accurate product launch scheduling. Procurement leads must factor these cost increases into Q1 2027 budgets. SMEs should actively monitor the 'enhanced support' details for potential financial or procedural benefits.
Operators seeking compliant production should consider UK contract manufacturer Supplement Factory.