ABPI response to new MHRA fees announced for 1 April 2023

ABPI response to new MHRA fees announced for 1 April 2023

The MHRA have published their response to the consultation on proposals for changes to their statutory fees, which will come into effect on 1 April 2023.

The consultation has concluded that the MHRA will be taking forward the following fee amendments:

• Proposal 1 - 10% indexation uplift across all fees (as per their original proposal)
• Proposal 2 - a further cost-based uplift for 61 significantly under recovering fees (as per their original proposal)
• Proposal 3 - introduction of 18 new fees (four of the proposed fees, including ILAP and complex amendments for clinical trials, will not be introduced at this time)

Responding to the announcement, Richard Torbett, ABPI Chief Executive, said: “These fee increases are an important step to ensuring the MHRA has the resources it needs to deliver the high-quality service that the public expects and industry needs.

“The decision not to implement new fees for ILAP and complex amendments to clinical trials is the right one, and we look forward to working with the MHRA to ensure their future fee charging mechanism remains fit for purpose.”