Since the United Kingdom’s exit from the European Union in 2020, there have been numerous changes in the procedures implemented to ensure that there is access to medicines for UK patients. One area of interest and a growing topic of discussion in the pharmaceutical industry is the International Recognition Procedure (IRP) which was introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) on 1 January 2024, replacing and expanding on the EC Decision Reliance Procedure (ECDRP).i
The introduction of the IRP has brought opportunities for faster market access for manufacturers by enabling the MHRA to conduct more targeted assessments by taking into account the expertise and decision-making of trusted regulatory partners.
The IRP also allows the MHRA to perform product lifecycle activities utilised for post-approval submissions including line extensions, variations (Type IB and Type II) and renewals for a medicinal product with an existing Marketing Authorisation (MA) provided by one of MHRA’s acceptable Reference Regulatory (RR) which include:
| Country or jurisdiction | Regulatory authority |
| Australia | Therapeutic Goods Administration |
| Canada | Health Canada |
| Switzerland | SwissMedic |
| Singapore | Health Science Authority Singapore |
| Japan | Pharmaceuticals and Medical Devices Agency |
| United States | Food and Drug Administration |
| European Union/European Economic Area | European Medicines Agency and Member State Competent Authorities of the EU, Norway, Iceland and Lichtenstein. (This includes approvals through the centralised, MRP/DCP and individual member state national routes) |
The IRP may also be used for Access Consortium approvals that did not include MHRA as part of the work-sharing procedure.i
IRP PROCESS
New IRP marketing authorization application (MAA)
A new MA may be achieved via one of two possible recognition pathways:
- Recognition A– Is applicable if the reference regulator MA has been granted within the previous 2 yearsi (60-day procedure, no clock stop)
- Recognition B– Is applicable if the reference regulator MA has been granted within the previous 10 years and fulfils at least 1 of the 24 listed criteria (110-day procedure with no more than 1 clock stop. If there are outstanding Major Objections at Day 110, formal advice on approvability will be sought from CHM and the timetable will revert to the national 210-day timetablei
Post-authorization IRP applications: variations and renewals
The IRP can be used during the lifecycle of products that have been initially authorized or subsequently varied via standalone national, MRDCRP or ECDRP routes. Conversely, where a product has been authorized via IRP, it is acceptable to submit standalone national post-authorization procedures including variations.i
Full details of the IRP submission process and requirements are provided on the MHRA website:
- https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure
- https://www.gov.uk/government/publications/international-recognition-procedure/ectd-guidance-for-irp-mas-and-lifecycle
WHO CAN APPLY?
To ensure that the applicant/Marketing Authorization Holder (MAH) can fulfil the submission requirements as well as all their legal obligations as holder of an MA, such as the obligations stated in Regulations 74 and 75 of the Human Medicines Regulations 2012, the applicant/MAH must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA and it is anticipated that the applicant for an IRP application is the same company or belongs to the same (legal) group of companies as the MAH of the RR procedure.i
In some situations, it may be possible to accept applications from third parties if the applicant can demonstrate and provide written assurance that all the legal obligations can be met at submission, during the assessment process and throughout the life of the MA.i
KEY ADVANTAGES OF USING THE IRP?
Expansion of international collaborations
The IRP allows the MHRA to consider the decisions of trusted regulatory partners both from the EU and globally; expanding international collaborations and reducing repetition of work for the health authorities and MAHs alike.i
Fast market access
Navigating the regulatory processes in the lead-up to the submission can be challenging and submitting a marketing application is a significant undertaking process, involving multiple stakeholders over a period of up to 2 years (if all goes to plan).
Expedited approval with review times of 60 days (Route A) and 110 days (Route B) are significantly shorter than the MHRA national route for MAAii which has a 210-day timetable. This will allow quicker market access for medicines authorized outside of the EU and reduce assessment pressure and time burden on the MHRA.
MHRA SUPPORT
For MAAs, the MHRA require an online eligibility form which determines the suitability for recognition pathway A or B. Applicants intending to submit via the IRP have the option of requesting pre-submission advice through a form and returning this to presubmission@mhra.gov.uk.iii
The IRP has been operational since 1 January 2024. In December 2024 a total of 265 IRP submissions (Type IB- 190, Type II- 75) were approved with 95-97% granted with the statutory timeframe.iv
MHRA Metrics for December 2024iv
| Work type | Average time to determination in days* | Numbers granted | % granted within statutory time |
| Type IB variations – all submission routes | 14 | 656 | 96 |
| Type IB IRP variations | 5 | 190 | 97 |
| Type II variations – all submission routes** | 73 | 256 | 76 |
| Type II IRP variations | 21 | 75 | 95 |
| Initials – NAS MAA national | 252 | 2 | 0 |
| Initials – established medicines MAA*** | 558 | 57 | 9 |
| Initials – established meds IRP route A | 55 | 22 | 100 |
| Initials – established meds IRP route A extended | 75 | 8 | 100 |
| Initials – established meds IRP route B | 90 | 6 | 100 |
| Initials – established meds IRP route B extended | 110 | 3 | 100 |
| Initials – NAS IRP route B | 98 | 5 | 100 |
* Regulatory clock on days from validation to determination
** Type II variations – This is a crude estimation of 90 days as there are different work types and different procedure types grouped together
*** Includes national and reliance route conversions
OTHER CONSIDERATIONS
Eligibility constraints
IRP is only applicable to:
- Chemical and biological new active substances and known active substances
- Generic applications
- Hybrid applications
- Biosimilar applications
- New fixed combination product applications
It is not applicable to:
- Bibliographic applications
- Traditional herbal registrations
- Homoeopathic registrations
Best use of IRP
What is your understanding of the IRP and have you used it for marketing applications? We are interested in hearing about your experiences around this topic and are happy to offer guidance on managing IRP submissions in the UK.
For more in-depth information and valuable insights into IRP and how it affects MAs in the UK, please watch our recent webinar titled “Navigating the UK International Recognition Procedure.”
About the authors:
Aashni Shah is a Senior Specialist, Regulatory Affairs at PharmaLex and sits within the UK and Ireland Regulatory Strategy and Procedure Management Team. Aashni has 4 years of experience in regulatory affairs and has a background as a pharmacist.
Dr Claire Stevenson is a Manager, Regulatory Affairs at PharmaLex and sits within the UK and Ireland Regulatory Strategy and Procedure Management Team. Claire has 10 years of experience in regulatory affairs across industry and consultancy.
Notes
iInternational Recognition Procedure – GOV.UK Updated 29 Jan 2024
ii The International Recognition Procedure – The United Kingdom’s new route for accelerated marketing authorization – Voisin Consulting 6 February 2024
iii https://www.gov.uk/guidance/pre-submission-advice-support 13 August 2024
iv https://assets.publishing.service.gov.uk/media/6788f08693d4eae3088bd2bd/MHRA-Performance-Metrics_MAA-V_2301-2412.pdf December 2024
v https://www.abpi.org.uk/media/blogs/2023/september/mhra-s-new-international-recognition-procedure-irp-how-does-it-shape-up/ 20 September 2023
