IRP - The one benefit from Brexit?
- Jackie Roberts
- Feb 10
- 2 min read
International Recognition Procedures
Jackie Roberts gives her thoughts on the International Recognition Procedure (IRP) and invites companies attending DCAT to meet with her and discuss the opportunities further.
“If I am honest there really isn’t much benefit from the UK leaving the European Union (Brexit). However, in the darkness of all the misleading promises and fake benefits we were given there is one procedure that has come out of it, which, I believe, is beneficial both to UK patients and to global pharma. I am talking about the MHRA’s IRP.
The IRP allows the MHRA to take into account the expertise and decision-making of trusted regulatory partners (including the FDA in the USA, the EMA in Europe, the PMDA in Japan, Health Canada, SwissMedic, HAS in Singapore and the Australian TGA) for the benefit of UK patients. The MHRA conducts a targeted assessment of IRP applications taking into account the work done in assessment by the trusted regulatory partner. This makes the application process much quicker (there is either a 60 or 110 day timetable dependent on the product). However, the MHRA does, of course, retain the authority to reject an application if they consider the evidence provided is insufficiently robust.
Why am I excited about this? It gives a way for products to be licensed in the UK possibly earlier and quicker than via traditional routes, which would be great for the patients who would benefit. Are you interested in finding out more and seeing if you could benefit from this expedited approach then please do contact me via LinkedIn or via the website. As I announced earlier I am in New York in March and planning to attend DCAT so if you are there and think this may be of interest please reach out to me and we can have a coffee and discuss.”
