Key Takeaways
- Companies using the UK’s International Recognition Procedure to apply for marketing authorizations can expect faster timelines when they use the EU as a reference regulator rather than the US or Canada.
- This is because EU dossiers are more likely to be eligible for the type A pathway under the IRP, as the requirements for granting a marketing authorization are similar to those of the UK.
- The UK MHRA is also looking at a new pilot project focused on the acceptance of approval decisions from the US Food and Drug Administration, which is set to be announced this year.
The UK’s International Recognition Procedure (IRP) allows the country’s drug regulator, the Medicines and Healthcare products Regulatory Agency, to take account of approval decisions taken by seven other world regulators when assessing marketing authorization applications (MAAs).
However, companies that use the European Medicines Agency as a reference regulator can expect to gain approval for their medicine within 60 days, while those using other reference regulators might face a longer wait, according to Tasneem Fatima Keshavji, head of the IRP at the MHRA.
This is because “a lot of [MHRA] requirements are similar to the EMA,” Keshavji said during the RAPS Euro Convergence 2025 in Brussels, Belgium, on 14 May.
She explained that the MHRA would need to “factor in some additional time” if it was reviewing a dossier prepared for the US Food and Drug Administration or Health Canada, for which “there will be additional material which we haven’t seen before, or that the company would need to prepare specifically for that UK dossier.”
The IRP has two pathways, and it is the type A route that has a 60-day timetable with no clock stop. Meanwhile, the B route has a 110-day timetable with one clock stop at day 70, giving the applicant up to 60 days to respond to any issues identified.
While companies can apply for an approval through the type A pathway if their drug has been authorized in a reference regulator country within the last two years, the MHRA can revert an application to the type B pathway for a plethora of reasons, which are listed on the MHRA website. Examples include medicines with UK-specific risk management activities that must be addressed, or if pivotal clinical data for the drug has been generated from single-arm studies.
Keshavji suggested that applications made using reference regulators from outside the EU were more likely to result in questions that would require companies to use the type B pathway, as this gives them more time to respond to MHRA requests.
She noted that applicants can still be asked questions under the type A pathway, but they must be prepared to answer these in a timely fashion without the need for a clock-stop.
The IRP was launched in January 2024 as a replacement for the European Commission Decision Reliance Procedure (ECDRP), which allowed the MHRA to take account of EU marketing approval decisions and came to an end on 31 December 2023.
The seven reference regulators that are recognized by the UK under the IRP are from Australia, Canada, the EU, Japan, Switzerland, Singapore and the US.
MHRA Wants To Speed Up National Route
Companies that are not eligible to submit applications through either type A or type B of the IRP, or who do not want to, can use the MHRA national procedure instead.
The national procedure has a timeline of 210 days, although the agency is “looking to try and shorten those when possible,” Keshavji stated.
She said that while the IRP timelines in general are shorter than the MHRA’s national assessment route, the IRP is “dependent on approval by another reference regulator, so it doesn’t necessarily mean that patients in the UK will gain access to the medicine as quickly as possible.”
Keshavji urged companies to “come in for a pre-submission meeting” with the MHRA to discuss which route was best for their product.
FDA Pilot Incoming
Keshavji pointed out that the UK also uses other regulatory reliance initiatives, such as the FDA-led Project Orbis, and said the MHRA was aiming to look at more ways of collaborating internationally.
“Some initiatives that are currently ongoing are also looking at ‘how can we accept dossiers from around the world? How can we actually accept an FDA dossier in the UK?’,” she said, adding that there was a “pilot that’s going to be running for this year” focused on this topic.
While Keshavji could not provide further information on the pilot, she said the MHRA wanted to “make things easier” for industry and “get medicines for patients quicker.”
Project Orbis, launched in 2019, provides a framework for international regulators to evaluate cancer drug filings concurrently or near-concurrently with the US FDA. Project Orbis partners are Australia, Brazil, Canada, Israel, Singapore, Switzerland and the UK.
The MHRA also participates in the ACCESS Consortium, which is an international regulatory reliance initiative that also includes regulators from Australia, Canada, Singapore and Switzerland.
