MHRA’s new International Recognition Procedure (IRP): how does it shape up?

Blog post from Dr Daniel O’Connor, ABPI Director of Regulatory and Early Access Policy.

The field of life sciences and medicine development has become increasingly global. Multinational firms must make informed and often challenging decisions about where and when to locate their activity. National regulatory frameworks are a key consideration when these decisions are made in boardrooms. It is therefore vital for regulators to provide a globally competitive approval system that is both proportionate and committed to ensuring patient safety, while also being attractive to inward investment and industry research and development.

Since the UK left the European Union (EU) at the beginning of 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a number of regulatory flexibilities for companies to consider when applying for their products to enter the UK market.

These flexibilities include:

• the MHRA joining the ACCESS consortium and Project Orbis
• setting up a Day 150 national route to marketing authorisation
• launching the Innovative Licensing and Access Pathway (ILAP) with ILAP HTA partners
• and relying on the European Commission decision for centralised procedures (European Commission Decision Reliance Procedure – ECDRP).

The ECDRP is due to end on the 31^st of December 2023 (currently under consultation). In its place the MHRA will launch a new International Recognition Procedure from the 1^st of January 2024.

Here we explore the attractiveness of the IRP compared to the other offers currently available and highlight the need for a clearer regulatory narrative about what each of these flexibilities mean in practice for product pipelines and the importance of creating a competitive end-to-end access ecosystem.

The International Recognition Procedure (IRP)

The MHRA recently published more details on the IRP. This new licensing route for medicines (pre and post authorisation procedures) allows the MHRA to conduct targeted assessments by recognising approvals from trusted partner agencies.

The IRP is open to applicants who have already received an authorisation for the same product from one of MHRA’s specified Reference Regulators with a right to reject applications if ‘insufficiently robust’. The seven countries / regions with approved Reference Regulators are Australia, Canada, European Commission [replaces ECDRP], Japan, Switzerland, Singapore and the USA.

There are two recognition timetables for initial marketing authorisations, Recognition A and B which are summarised in the table below and described in detail in the MHRA’s guidance. Suitability for either A or B is determined by an eligibility form to be completed by the Applicant 6 weeks before the planned submission.

Until parts of the Windsor Framework related to medicines come into force in January 2025 products falling within the scope of the EU Centralised Procedure can only be authorised in Great Britain.

Key summary of Recognition A and B

How does the IRP compare to other MHRA offers?

New approaches to regulatory approvals that provide advantages over current procedures are welcome. The IRP is an additional flexibility for medicine developers, which may offer some added value for products approved in other jurisdictions.

However, due to the extensive B criteria, most innovative products will likely fall under Recognition B, where the ‘Day 110 approval pathway with clock stop’ is not particularly competitive versus the national procedure (or as favourable as compared to the ECDRP).

In terms of the MHRA’s view, that these changes pave the way for faster product approvals and thus will provide faster access for UK patients, it is not clear what this route is faster than as the MHRA must wait first for the product to be approved elsewhere. It is also not yet clear how the Agency perceives the relative importance of each of the flexibilities listed above in supporting the life sciences ecosystem and early patient access.

There is, therefore, a need for a clearer narrative on the MHRA’s regulatory flexibilities and the impact of the IRP, not only as a route to market and patient access, but also on other activities such as engaging with the ILAP and the Early Access to Medicines Scheme (EAMS), siting clinical trials in the UK and seeking scientific advice. Future further interpretation of these regulatory opportunities will help companies to focus their resources and pipelines, optimising development programmes and ensuring engagement with the right regulatory route at the right time.

References

European Commission (EC) Decision Reliance Procedure

European Commission (EC) Decision Reliance Procedure - GOV.UK (www.gov.uk)

Consultation on end to the European Commission Decision Reliance Procedure - GOV.UK (www.gov.uk)

Access Consortium

Access Consortium - GOV.UK (www.gov.uk)

Project Orbis

Project Orbis - GOV.UK (www.gov.uk)

National route to marketing authorisations

150-day assessment for national applications for medicines - GOV.UK (www.gov.uk)

Innovative Licensing and Access Pathway (ILAP)

Innovative Licensing and Access Pathway - GOV.UK (www.gov.uk)

International Recognition Procedure  

International Recognition Procedure - GOV.UK (www.gov.uk)

Early Access to Medicines Scheme (EAMS)

Apply for the early access to medicines scheme (EAMS) - GOV.UK (www.gov.uk)