Sep 23, 2022

The UK Medicines & Healthcare Products Regulatory Agency (MHRA) has published a consultation for industry comment regarding a proposed increase in fees the agency charges to run programs that serve patients, the public and industry. The aim of the consultation is to seek the views of stakeholders on proposals for changes to the agency’s statutory fees. The consultation closes at 11:45 p.m. on November 23, 2022. The fee increases are the largest that the agency has proposed in years. The last rate review was in 2016.

MHRA opens consultation for industry comment on fee increases

The proposed fee adjustments set out in the consultation are designed to make sure the programs cover their costs. The increases mirror the agency’s rising costs in staff spending, which makes up half of the agency’s budget. Some other cost increases, such as for information technology and laboratories, will be absorbed through cost-cutting measures.

The MHRA aims to raise fees on a number of programs including:

  • A 10% indexation uplift across statutory fees
  • An uplift for 61 significantly under-recovering fees for services that require cost recovery
  • The introduction of 22 new fees for services that require cost recovery since the last fee changes were in 20016/2017 for medicines and 2017/2018 for medical devices

The fees are expected to take effect in 2023 and cost recovery will be monitored for the first year after implementation to make sure the new fees are covering actual costs.

Emergo by UL will continue to post updates to MHRA guidance as it becomes available.

Additional UK medical device regulatory resources from Emergo by UL:

  • UK Responsible Person (UKRP) and Brexit transition consulting for medical device companies
  • Process Chart: UK regulatory pathway for medical devices

Author

  • Kathryn Burke's picture
    Kathryn Burke

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