On 26th May 2023, the MHRA released further details on the International Recognition Procedure. This was first announced in January in anticipation of what would replace the existing ‘Reliance Procedure’ (due to end Dec 2023), a post-brexit route to allow UK/GB to recognise the assessment of the EMA/EU. We are likely to hear more about this in August however I have started to breakdown my thoughts on the topic.
What we know so far
The MHRA announced that new regulatory recognition routes for medicines will be established using approvals from ‘trusted regulatory partners’, to include:
Australia (TGA) 1, 2
Canada (Health Canada) 1, 2
EU (EMA)
Japan (PMDA)
Switzerland (Swissmedic) 1, 2
Singapore (HSA) 1, 2
United States (FDA) 2
1 Already part of the Access Consortium
2 Already part of Project Orbis
There is a clear trend that most of the countries listed above are also involved in the Access Consortium or Project Orbis, both of which the MHRA joined in Jan 2021 and have suggested they will continue to be part of these initiatives, while offering this additional route. The MHRA will also continue to offer their Innovative Licencing and Access Pathway (ILAP) alongside this additional route, referencing this has a ‘dual approach’ and fully intend on contributing towards the UK’s ambition to be a global science superpower. It was recently announced that the MHRA will receive £10m in funding to fast-track patient access to innovative medicinal products, making it clear that they intend spending this on the development of global recognition routes.
From the announcement it is expected that the International Recognition Procedure will be ready by Q1 2024 – since the existing reliance route with the EU ends 31st Dec 2023, so I hope that they actually mean 1st Jan 2024!
While we await further details on this new recognition route, I will breakdown what my thoughts are and potential challenges…
Advantages of the framework
As seen with the existing EU reliance route, approval of new medicines has been possible using much less resource at the MHRA – inevitably allowing earlier access to medicines than we otherwise would have seen. Going forward, in theory gaining a marketing authorisation in the UK should be more predictable in terms of approval timelines. This, along with cost reduction to industry in terms of both local and regional resource requirements and, one assumes application fees, makes the UK an attractive market to prioritise ‘Wave 1’ product launches.
Expected challenges
The MHRA’s post-Brexit performance has taken a hit and introducing another new way of working will increase complexity and require resource, therefore continued patience will be necessary. However, in order to allow industry to take full advantage as soon as the new route becomes available, the MHRA should aim to release practical information about how it will work ASAP, otherwise uncertainty will be prolonged.
The MHRA have stated that they will reject applications if the evidence provided is considered insufficiently robust, however this must be a foreseen challenge at the agency given that there will be differences in requirements during clinical trials for example.
Also challenging will be creating aligned Product Information when the SmPC, PIL and label requirements and layout are so different between markets outside of the EU.
Unknown details
I see this working in much the same way as the soon-to-end reliance route with the EU/EMA, however the announcement does refer to routes, suggesting multiple different requirements depending on the agency chosen for recognition. Also unknown is whether recognition of the ‘EU’ means the EMA or if this is extended to all member states of the EU.
The MHRA specifically states and repeats reference to allowing access to ‘cutting edge medicines’ – therefore could there be a qualifier or will all medicines be included…
In the initial announcement in January, the MHRA stated that industry ‘can continue to make an application through the MRDCRP as usual after 31 December 2023’, however this hasn’t been referenced in the latest announcement. Given that the Windsor Framework was announced in February, firmly closing shut the window to the EU through Northern Ireland (as Concerned Member State known as ‘UK(NI)’), I can’t help but suspect this will no longer be possible.
No practical details on the submission process, timelines or documentation requirements have been released, nor have they confirmed if these routes just cover the MA or will it include variations also. Focus on the EU recognition route should be an absolute priority at the MHRA!
Considerations for the future
Despite many questions arising, this is a big turning point for the way industry can gain marketing authorisations for the UK, and the MHRA have already refenced their intention for similar routes for medical devices. With advantages for both industry and patients this opens up another set of questions and possibilities for the future…
The announcement certainly suggests that recognition is ‘one-sided’, however since the MHRA refer to the recognised agencies as ‘Partners’, could this suggest that these markets may recognise the MHRA’s assessment under this same framework, if not now, potentially in the future?
Whilst the MHRA are allowing industry to take advantage of other regulator’s assessments, the MHRA maintain that they will have sole responsibility for approving all applications to ensure products are safe and of sufficient quality. It is equally important that the MHRA need to work hard to maintain their image as a leading regulator through their own merit. Historically, the MHRA has been a well-respected and leading Health Authority, with them initiating this framework, does this take healthcare one step closer towards the globalisation of therapeutic products industries.
We still await further details on the Windsor Framework, which undoubtedly complicates matters and I would advise against any expectations that you will be able to easily apply for a product licence (from anywhere other that the EU) in Q1 2024, although would happily be proved wrong on this!
I eagerly await further details and clarification on the open questions above, once available I will post another update.
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While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
