NHS: Drugs
The question
To ask the Secretary of State for Health and Social Care, what performance improvement targets he has sought from the MHRA on bringing down the licensing backlog of generic and biosimilar medicine applications.
Answered by Karin Smyth
The Medicines and Healthcare products Regulatory Agency’s (MHRA) focus has been to ensure all applications received through all routes are processed on time. The MHRA has now embedded improvements in processing licencing applications into standard working practice. Milestones for licencing clearance during 2024 were achieved in line with the business plan commitment to remove backlogs, including generics and biosimilars by the end of March 2025.
During 2024, the MHRA has been working through a high number of applications to return to working to statutory timelines. From 1 September 2024, all applications submitted, regardless of application pathway, are being completed within statutory timelines. The Agency’s original background of national marketing authorisation applications has been eliminated, with decisions made for over 1,680 licence applications in 2024.
The MHRA has been working in close collaboration with health system partners and industry to ensure that robust, appropriate and prompt decisions are made. The MHRA is on track to clear all statutory backlog activities by the end of March 2025.
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