Accelerate UK market entry: Leverage the MHRA's new International Recognition Procedure

This blog is part of The Regulatory Navigator series, where we explore the evolving regulatory landscape with actionable insight from Parexel's experts, sharing their experience to maximize success for clinical development and patient access.

With the UK’s departure from the EU in early 2020, Great Britain ceased to be a participant in European regulatory routes such as centralized, decentralized and mutual recognition procedures. In response, Medicines and Healthcare products Regulatory Agency (MHRA) has introduced regulatory flexibilities aimed at streamlining the process for pharmaceutical companies seeking to bring products to the UK’s sizeable 70 million population. The MHRA's International Recognition Procedure (IRP) is one of several regulatory routes recently implemented. 

*For innovative medicines, there is a potential for accelerated approval in 150 days. 
Figure 1. MHRA licensing routes 

The IRP represents a significant evolution in the UK's approach to medicines licensing. This pathway enables the MHRA to conduct targeted assessments by recognizing approvals from trusted partner agencies, potentially expediting the authorization process for certain products. As well as possible faster market access in the UK, this approach also provides opportunities for companies to strategically reconsider their global regulatory submission sequences, potentially leading to more efficient and cost-effective drug development processes.

The IRP recognition routes: A comparison 

Eligibility: The IRP is open to applicants with an existing authorization from MHRA-specified Reference Regulators which are: Australia, Canada, EU (European Medicines Agency (EMA) and Member State Competent Authorities of the EU, Norway, Iceland and Lichtenstein), Japan, Switzerland, Singapore and the USA. 

Timeframe: There is a dual-route system (IRP Recognition A or B) that features two different timeframes and eligibility criteria, based on the MHRA’s perception of risk and complexity. Both Recognition A (60-day timeline) and Recognition B (110-day timeline)   apply exclusively to initial marketing authorizations and line extensions.¹ The key features of those are described in Figure 2, and Table 1. 

While the IRP timelines are in general shorter than UK national procedure, they are dependent on the approval from another regulator.

Figure 2. National UK procedure vs IRP timelines 

*Non-exhaustive list
Table 1. Key elements of Recognition A and Recognition B in the IRP. 

IRP application requirements and scope

• eCTD: This should be in EU format with a UK-specific Module 1, meaning that some revisions and editing may be needed. The MHRA have acknowledged that they want to further improve and have suggested future possibility to accept a Food and Drug Administration (FDA) dossier in the UK, planning to introduce a “pilot that’s going to be running for this year” focused on this topic.^2,3
• Name considerations: MHRA IRP guidance states that the standard MHRA requirements for a UK marketing authorization will apply. Per the UK national submission sponsors should contact the MHRA invented name mailbox prior to submission for feedback, as the invented name may not be acceptable to MHRA depending on existing UK national licences which may bear look-a-like or sound-a-like similarities to the invented name that has been approved in other regions. This may result in safety concerns, and an alternative invented name would need to be proposed, meaning a divergence in brand names. 
• Applicability for post-authorization procedures: In addition to initial applications, the IRP can also be used for line extensions, variations (Type 1B, Type II) and renewal applications (including annual renewal of conditional MAs and annual reassessment of exceptional circumstance MAs). IRP can be used during the lifecycle of products that have been initially authorised or subsequently varied via standalone national, MRDCRP or ECDRP routes. On the contrary, where a product has been authorised via IRP, it is acceptable to submit standalone national post-authorisation procedures, including variations.¹

How companies can benefit from IRP 

The new MHRA licensing routes present the potential to reshape the established global regulatory strategy of traditionally applying for an NDA/BLA in the US before proceeding with EMA, followed by UK, Switzerland and Japan.⁴ By leveraging FDA approval, it may be possible to register your product in the UK prior to EU, for example. Additionally, for an APAC company with an existing product authorization in Japan, Singapore or Australia, the IRP offers a potentially streamlined route to the UK market.

With the UK’s withdrawal from EMA’s centralized procedure as part of Brexit, IRP can also partially mitigate one of the impacts; UK approvals could be relatively close to EU approval, or potentially earlier if another reference regulator is leveraged.

MHRA offers pipeline meetings as early as 2-5 years before submission to help inform applicants’ regulatory strategy.²

Additional advantages and disadvantages of IRP route include:

Table 2. Pros and cons of the IRP. 

Conclusions

The IRP enhances the MHRA's regulatory toolkit and offers opportunities to accelerate UK patient access to medicines while offering applications a more efficient path to regulatory approval. By leveraging previous approvals, it eliminates the need for comprehensive regulatory reviews. MHRA meet key assessment targets, as evidenced by their monthly published performance reports. 

At Parexel, we view the IRP as a prime option for UK product registration. 

With experts across multiple regulatory disciplines who are former MHRA assessors, Parexel is ideally positioned to help you take advantage of the opportunities presented by the IRP and other MHRA flexibilities. This includes: 

1. Strategic planning: To determine the most appropriate regulatory pathway for your product, considering all available options – as well as how the UK application fits with your overall global regulatory strategy.
2. Application support: Preparing and submitting IRP applications, ensuring compliance with all MHRA requirements.
3. Regulatory intelligence: Up-to-date insights on evolving MHRA policies and procedures, helping you stay ahead of regulatory changes.
4. Holistic approach: To consider not just the regulatory aspects but also the broader implications for market access and commercial strategy in the UK, and beyond. 

Please get in touch, we’re always available for a conversation.  

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References

1. MHRA Guidance on International Recognition Procedure (updated 13 May 2025)
2. Tasneem Fatima Keshavji (MHRA), RAPS Euro Convergence, 14th May 2025
3. Pink Sheet, UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada, Eliza Slawther 15th May 2025
4. Global Pharmaceutical and Biologics Regulatory Strategy, second edition. Chapter 7 CMC Regulatory Strategy. Antonelli S, Craig M. Regulatory Affairs Professional Society (RAPS) Publishing

Notice: This information is provided for educational purposes only and should not be construed as legal or regulatory advice. Readers should not act upon this information without seeking advice from professional advisers.

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