We all know about the European Commission Decision Reliance Procedure (ECDRP) and that it has been extended to 31st December 2023. What my article will explore is what will happen on 1st January 2024 when the Medicines and Healthcare Products Regulatory Agency’s (MHRA’s) new international recognition framework will be in place.

This announcement will be encouraging news to pharmaceutical companies that often see Great Britain (GB) as a key part of the Wave 1 launch strategy. This new framework promises to increase the routes to market for GB. Whilst currently the ECDRP allows GB to align to EU approval, this new framework may give GB the advantage of faster approval by recognising other regulators.

Responding to the decision, David Watson, Executive Director, Patient Access (ABPI) said:
“The MHRA’s pragmatic decision regarding GB marketing authorisation applications is an important one for our industry. Pharmaceutical companies now have the clarity needed to inform their regulatory decisions for the year.”

In this new scheme the MHRA states “you can apply to MHRA through our new international recognition framework, which will have regard to decisions already made by the European Medicines Agency and certain other regulators.” It is not yet known what other regulators might be considered here; however we already have project Orbis and this sees MHRA working with a number of regulators across the globe such as USA, Australia, Canada, Singapore, Switzerland and Brazil. In addition we also have the Access Consortium that involves MHRA collaborating with Australia, Canada, Singapore and Switzerland.

What is interesting about the international framework is that it seems like a great leap forward to having a simplified route to market for the UK and this may somewhat ease the pressure on regulatory functions following Brexit. What is equally intriguing for me is trying to predict which other regulators around the globe could be involved. Could it be the same regulators mentioned for the other schemes above or are there other regulators that will come into play here…?

There are still many details to be released and many questions to be answered: we all know how this works for the Centralised Procedure in the EU, as that’s what we’ve been used to, but how will this look when “certain other regulators” are involved?

If you want to read the news story from the MHRA this can be found here. I’m sure to be keeping an eye out for when any further information is released on the new international framework so look out for my next article on this topic.