The MHRA has published important updates to the International Recognition Procedure (IRP), with the revised guidance taking effect from 1 September 2026. While applications can still be submitted under the current guidance until 11:59pm on 31 August 2026, organisations planning future Marketing Authorisation Applications (MAAs) should review their regulatory strategy now.
For some applicants, particularly those intending to use the Recognition B pathway, the changes could have a significant impact on submission planning and eligibility.
Recognition B Eligibility Window Reduced
One of the most significant updates is the change to Recognition B eligibility.
Under the revised guidance, the Reference Regulator (RR) approval must have been granted within the previous five years. Previously, approvals granted within the last ten years could be used.
Applicants currently planning to rely on an RR approval that falls within the previous ten-year window—but is older than five years—should ensure their MHRA submission is made before 31 August 2026. Missing this deadline may require a change in regulatory strategy.
Where there is an urgent public health need, the MHRA may consider national fast-track requests. In other situations, applicants may need to pursue the national procedure instead.
Earlier Regulatory Planning is Now Essential
The updated guidance reinforces the importance of early planning.
For products containing a new active substance, applicants must notify the MHRA at least eight weeks before submission to support resource planning for the assessment.
Similarly, Eligibility Forms must be submitted at least eight weeks before the planned submission date for all new Marketing Authorisation Applications, including line extensions, to confirm the appropriate regulatory pathway.
The updated eligibility checker provides clearer decision criteria, while the revised guidance clarifies how applications are allocated to the Recognition A, Recognition B or national procedures.
Although not mandatory, the MHRA strongly recommends a pre-submission meeting for applications involving new active substances or novel therapies. These can now be requested through the new “Contact Us” section of the IRP webpage, together with the updated IRP query template.
Greater Focus on Submission Quality
The revised IRP guidance also places greater emphasis on the quality and completeness of the submission package.
Additional clarification has been provided on the documentation required to support a Marketing Authorisation Application, including guidance on the location of Reference Regulator documentation within Module 1 of the eCTD. Used alongside the updated IRP Validation Checklist, these improvements are intended to reduce validation errors and support a smoother 14-day validation process.
Validation requirements have also become more stringent.
Applicants will now have only one opportunity to respond to a Validation Correction Request (VCR), bringing the IRP process into closer alignment with the national procedure. Failure to address a VCR satisfactorily will result in the application being declared invalid. Where validation is delayed beyond the planned procedure start date, the assessment timetable will not begin until all validation issues have been resolved.
These changes make dossier readiness more important than ever before.
Recognition B Timelines
The updated guidance also provides revised submission dates for Recognition B applications intended to align with the Commission on Human Medicines (CHM) meeting schedule.
Recognition B applications continue to include a single clock-stop at Day 70, with applicants given 60 days to respond. Where significant issues remain at Day 110, the MHRA will seek formal advice from the CHM and the timetable will revert to the national 210-day assessment.
Throughout the assessment process, the MHRA also retains the right to extend timelines, request withdrawal of an IRP application or require resubmission via the national procedure where appropriate.
The most effective way to minimise these risks remains the same: thorough preparation, complete documentation and timely responses throughout the procedure.
What Do These Changes Mean for Applicants?
Collectively, the revised guidance places greater emphasis on:
- Earlier regulatory planning
- Higher-quality submission packages
- Careful consideration of Reference Regulator approvals
- Assessing the regulatory impact of moving from the IRP to the national procedure if required
The organisations most immediately affected are those planning a Recognition B application using a Reference Regulator approval that is more than five years old, particularly where submission is planned after 31 August 2026 or where delays could push the application beyond that deadline.
These applicants should review their regulatory strategy as soon as possible. Where the Recognition B pathway is no longer available, organisations should consider whether an alternative Reference Regulator approval is available or whether the national procedure is now the most appropriate route.
Encouragingly, the MHRA has indicated that significant progress has been made in consistently meeting statutory timelines for national procedures, meaning the impact of changing pathway may be less significant than previously anticipated.
Looking Ahead
Overall, the updated MHRA International Recognition Procedure introduces greater clarity around pathway eligibility, documentation requirements and validation expectations. While the revised guidance raises expectations around planning and submission quality, it is also intended to deliver a more efficient, predictable and streamlined assessment process.
For organisations planning future MHRA submissions, now is the time to review regulatory strategies, confirm Recognition B eligibility and ensure dossiers are fully prepared before submission.
How Acorn Regulatory Can Help
Acorn Regulatory’s experienced Regulatory Affairs team supports pharmaceutical companies throughout every stage of the MHRA International Recognition Procedure, from IRP eligibility assessments and regulatory strategy through to dossier readiness, eCTD submissions, validation planning and ongoing regulatory support.
If you are planning an upcoming MHRA submission or would like to discuss how these changes could affect your regulatory strategy, we’d be delighted to help.
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