DR P. MARAZZI/SCIENCE PHOTO LIBRARY
Marketing authorisations from the Medicines and Healthcare products Regulatory Agency (MHRA) for established medicines and variations to existing approvals are running more than 100 days over their statutory limits, data have shown.
MHRA data for January 2024 show that current timescales for regulatory decisions for established medicines in January 2024 were an average of 333 days for national routes (application for a UK, Great Britain or Northern Ireland marketing authorisation), falling outside the statutory timescale of 210 days. For reliance routes (the procedure that allows the MHRA to grant a licence, relying on approval in the European Union), a decision took an average of 195 days, versus the statutory timescale of 67 days.
The data also show that, in December 2023, timescales for authorisation approval of established medicines were 496 days, and 253 days for reliance routes.
As of 4 January 2024, there were also 1,167 overdue individual product licences (past the 210 day limit).
In a statement published alongside the data on 15 February 2024, the MHRA said it “understand[s] the vital importance of efficient regulatory assessments” and said it was “taking urgent action to deliver improvements to timescales in established medicines”. It added that this includes “taking significant steps to assess applications for medicines approvals within statutory timeframes”.
On 1 March 2024, the MHRA introduced changes to its process to ensure applications for marketing authorisations are complete on initial assessment, or as soon after submission as possible, with incomplete applications refused, in an attempt to reduce timescales.
The MHRA said the measures “are already resulting in significant improvements, and we will continue to publish monthly updates providing applicants with transparent information on expected timescales”.
In May 2023, the MHRA announced a new fast-track international recognition route for medicines, using pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States, which has been in place since 1 January 2024. The MHRA said applications through this new route were being assessed within expected timescales and will be added to performance data publication from March 2024.
Commenting on the data, a spokesperson for the British Generic Manufacturers Association said: “We welcome the targets put in place by the MHRA but it is too early yet to tell how successful they will be in meeting those objectives.
“We have been very concerned about delays as, in some instances, licences which should typically take 12 months to approve were taking two years or more. Going forwards, we would like to see the MHRA prioritise reducing the generics licensing backlog and fund and commit to a return to most licences being determined within 12 months, with changes to existing licences completed within 3 months.”
Dan O’Connor, director of regulatory and early access policy at the Association of the British Pharmaceutical Industry, said: “Our members are concerned about the existing delays in securing MHRA approvals for established medicines, and we are working with them and other key industry stakeholders to help resolve this issue. Strengthening the development, regulation and adoption journey for new and established medicines and vaccines is essential to improving patient access to treatment and making the UK attractive to global research and investment.”
A spokesperson for the MHRA said: “We are working to reduce timelines by bringing in additional resources and to develop processes that will result in significantly improved response times while protecting patient safety.”
