The MHRA has launched an online eligibility checker tool for applications submitted via its International Recognition Procedure (IRP) framework which becomes operational in early 2024.
Medicines manufacturers can now use this tool to determine whether their marketing authorisation application is eligible for the IRP and identify which route – A or B – to follow prior to submission.
Route A is intended for products with overseas regulatory approvals granted within the previous two years and without significant complex factors. It allows for an MHRA assessment time of 60 calendar days. In contrast, Route B is ideal for cases requiring additional assessment or inspection activity, with an MHRA processing window of 110 days.
“From today, we encourage applicants to begin to use the tool in readiness for making submissions via the International Recognition Procedure from January 2024,” said Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access.
“Once IRP is fully up-and-running we will have created a further route for bringing new medicines to UK patients.”
The IRP allows the agency to take into account the expertise of international trusted regulators to make an approval decision, meaning that innovative medicines approved in these countries will be able to reach patients quicker. The current list of trusted partner regulators is: Australia, Canada, the EU, Japan, Switzerland, Singapore and the USA.
Further reading:
Regulatory Rapporteur: MHRA publishes recognition route revised guidance: https://www.regulatoryrapporteur.org/mhra-publishes-recognition-route-revised-guidance/413.article
Regulatory Rapporteur: MHRA seals deal for fast international recognition routes: https://www.regulatoryrapporteur.org/industry-news/mhra-seals-deal-for-fast-international-recognition-routes/306.article
Regulatory Rapporteur: Does sole dependence on reliance models contribute to a sustainable healthcare ecosystem? https://www.regulatoryrapporteur.org/does-sole-dependence-on-reliance-models-contribute-to-a-sustainable-healthcare-ecosystem/250.article
