MHRA Plan To Raise Fees Will See Big Hike For Switch Applications

UK regulator MHRA has set out a proposal to raise fees across the board by at least 10% for its regulatory work related to medicines and medical devices. A select number of fees will see even bigger increases, with the cost almost tripling for Rx-to-OTC switch applications.

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The UK’s Medicines and Healthcare products Regulatory Agency’s is planning to increase the fees it charges for its work with big hikes proposed for Rx-to-OTC switch applications.

From 1 April 2023, the agency wants to raise all statutory fees by at least 10% to ensure it fully recovers its costs. A consultation on the proposed uplift to its charges is running until 23 November.

Noting that the last fee changes for medicines and medical devices came in 2017 and 2018 respectively, MHRA said a recent review found that numerous areas of its work are under-recovering. The UK government in April 2022 reclassified the MHRA from a Trading Fund to a market regulatory agency meaning that it is no longer able to retain and rely on cash reserves to manage areas of under-recovery.

The proposed fee adjustments fall into three categories:

1. A 10% indexation uplift across statutory fees

2. A further uplift for 61 significantly under recovering fees to achieve cost recovery

3. The introduction of 22 new fees for services that require cost-recovery since the last fee changes

The 10% increase in fees will apply across MHRA’s regulatory activities, such as marketing authorizations, pharmacy (P) medicine to general sales list (GSL) reclassification applications, scientific advice and safety reviews. For example, the fee for a P-to-GSL reclassification will rise from £8,162 ($9,376) to £ 8,162.

According to MHRA the 10% uplift is linked to staff costs, which account for over half of the agency’s total expenditure.

Hike In POM-to-P Switch Fees

The additional increase for the significantly under recovering fees will apply to a range of activities including prescription-only medicine to P medicine reclassifications, reclassification variations (type IB), site inspections, new medical device registration, and notification charges for class I, IIa, class IIb devices.

For example, the cost of a POM-to-P switch application will almost triple from £11,992 to £33,003. This fee applies to both new marketing authorizations and variations.

The full-day rate for a good manufacturing practice inspection will rise from £2,655 to £3,651, while the fee for registering a new medical device has been set at £240, up from £100.

With regard to these fees, the MHRA said recent operational improvements had given it a greater understanding of the resources required to carry out its work.

The 22 new fees introduced by the agency mainly apply to applications for innovative prescription-only medicines, as well as complex amendments to clinical trials.

MHRA said the proposed increase in fees would ensure the agency is financially sustainable in the long-term and able to deliver a responsive, innovative and efficient regulatory service that facilitates access to high-quality, safe, effective and innovative medical products.