MHRA: Statutory Fees for Regulatory Services to Increase in Line with Inflation from April 2027

• The MHRA has launched a consultation on proposed changes to statutory fees, which will take effect from April 2027.
• The proposals include increases to most fees in line with inflation, targeted changes for selected services, enhanced service standards, and support for eligible small and medium-sized enterprises.
• The agency is seeking feedback on how to improve its support for small and medium-sized enterprises, which are eligible for reduced fees.
• The consultation closes on 25 September 2026, and lawyers and compliance officers should monitor the proposed changes to ensure clients comply with new regulations.

The proposals include increases to most fees in line with inflation, targeted changes for selected services, enhanced service standards, and support for eligible small and medium-sized enterprises.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposed changes to statutory fees, which are set to take effect from April 2027. The MHRA is seeking views on the proposals, which include increases to most fees in line with inflation, targeted changes for selected services, enhanced service standards, and support for eligible small and medium-sized enterprises. The agency aims to ensure that it continues to recover the cost of delivering its regulatory services while driving improvements in service reliability, predictability, and timeliness.

The consultation covers a range of proposals, including updates to scientific advice and medical device post-market surveillance services. The MHRA is also seeking feedback on how to improve its support for small and medium-sized enterprises, which are eligible for reduced fees. The agency has set a deadline of 25 September 2026 for responses to the consultation.

The proposed changes to statutory fees are part of the MHRA's ongoing efforts to ensure that it recovers the cost of delivering its regulatory services. The agency has a duty to recover its costs through fees, which are set by Parliament. The proposed increases to most fees in line with inflation are intended to reflect the rising costs of delivering regulatory services. However, the agency is also seeking feedback on targeted changes for selected services, which could have implications for businesses and individuals who rely on these services.

The proposed changes to statutory fees have significant implications for businesses and individuals who rely on MHRA regulatory services. The increases to most fees in line with inflation may impact clients' regulatory costs and compliance obligations from April 2027. Lawyers and compliance officers should monitor the proposed changes, as they may require adjustments to be made by clients to comply with new regulations. The consultation also highlights the importance of ensuring that regulatory service standards are maintained while driving improvements in service reliability, predictability, and timeliness.

Lawyers and compliance officers should monitor the proposed changes to statutory fees, as they may impact clients' regulatory costs and compliance obligations from April 2027.

Source: Original reporting via GOV.UK