2023 has brought us two further ‘Brexit hangovers’… the International Recognition Procedure (IRP) and the Windsor Framework!
Fusion Pharma have been closely monitoring the Medicines and Healthcare products Regulatory Agency (MHRA) guidance, attending key webinars/conferences and working alongside trade associations to feedback challenges to the MHRA in order to update the guidance to alleviate some of the burden to Industry. We have been supporting our clients by providing strategic advice on how to successfully implement the changes and mitigate against the challenges these bring.
The European Commission Decision Reliance Procedure (ECDRP) will come to a close on 31st December and be replaced with the IRP. Essentially, this is an iteration of the existing ECDRP however there are some differences that Regulatory Affairs need to be aware of including the minor, but distinct, changes in submission requirements and approval timelines.
In addition to continuing to recognise the EU, there are 6 other markets that can be used as a ‘Reference Regulator’ – whilst this may sound attractive and exciting, major consideration has to be given to the practical aspects of recognising a market that has a different regulatory framework. There is a strong likelihood of unforeseen problems arising during assessment by the MHRA, therefore my advice would be to manage expectations internally and build in buffers to your expected approval timelines. The introduction of the IRP will certainly be a case of ‘on the job learning’, with an element of trial and error.
The next 12 months will be crucial for the MHRA to demonstrate its success and give Pharma the reassurance it needs ensure the UK once again becomes a firm ‘wave 1’ market to launch in.
In contrast, the Windsor Framework has little room for trial and error and has to be implemented effectively in order to avoid being out of stock and/or having large writing off costs. Although its introduction attracts a lot of time and resource, I have confidence that it will bring more consistency and simplicity to the way in which medicines reach patients in Northern Ireland (although this may not be realised until Q1/2 2025).
There are two major issues pending (at time of writing): 1) when can ‘UK only’ be added to PLGB packs, and 2) can PLGB packs released to GB be distributed to Northern Ireland after 1st Jan 2025? Both points are being discussed between MHRA, Department of Health and Social Care (DHSC) and trade associations, it looks promising but time is running out before Industry has to put in place plans to mitigate against these two points.
We will continue to monitor both topics and bring to you any useful advice and guidance updates. Our Webinar on the Windsor Framework was hugely successful and we will be hosting a webinar series dedicated to the IRP, starting in February with an overview and summary. You can register your interest here.
