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MHRA International Recognition Procedure

Tue 26 March 2024Reading time: 5 minutes

Launched at the start of the year, the UK Medicines and Healthcare products Regulatory Agency's (MHRA) new “International Recognition Procedure” (IRP) has approved its first MAA for Amgen’s bone cancer drug Xgeva (denosumab). The IRP is one of several efforts by the regulator to streamline the approval of new medicines and expedite access to new drugs for patients.

Replacing the European Commission’s Decision Reliance Procedure (ECDRP) and allowing the MHRA to 'recognise' the expertise of specific Reference Regulators (RR) in other countries (Australia, Canada, Switzerland, Singapore, Japan, USA and European Union/EEA) when evaluating applications for medicines already authorized elsewhere, it can offer certain companies an alternate regulatory pathway to UK Marketing Authorisation (MA). This Need to Know provides some key information about this procedure and evaluates its benefits to the Industry.

1. What is it?

As a result of the departure from the European Union (EU), the MHRA has implemented various initiatives within its national regulatory framework to stay globally competitive. While these may not all be completely innovative compared with other global regulators, they do afford some flexibility and opportunities for pharma companies considering the UK market for its products:

  • Joined the Access consortium and Project Orbis promoting international collaboration with regulatory partners
  • A 150-day national route to marketing authorisation for ‘high quality’ applications
  • Launch of the Innovative Licensing and Access Pathway (ILAP) with ILAP HTA (Health Technology Assessment) partners
  • Reliance on the European Commission decision for centralised procedures (ECDRP) and on authorisations via the EU Decentralised (DC) or Mutual Recognition (MR) Procedures (MRDCRP)
  • Streamlining the approvals process for established medicines

(Further information on these other regulatory procedures can be found in Regulink’s Insights).

The IRP is another recent flexible regulatory pathway, implemented from 1st January 2024, providing an accelerated registration route to UK market, whereby the MHRA recognises the experience and decision-making of its international partner regulatory agencies in providing authorisations for the same product.

The MHRA specified RRs include Australia, Canada, European Commission (replacing ECDRP, and incorporating MRDCRP), Japan, Switzerland, Singapore and the USA.

2. What are the requirements?

For initial Marketing Authorisation Applications (MAA), there are two recognition timetables, Recognition A and B, which are outlined in the following table. Detailed guidance has been provided by the MHRA.

With both timetables, suitability for use is determined by an eligibility form that must be completed 6 weeks prior to the planned submission.

Applicants/ MA holders must be established in the UK (GB or NI) or EU/EEA to use the IRP. Although it is expected that the Applicant company belongs to the same company/ same (legal) group of companies as the MA holder in the RR procedure, it will be possible for third parties (“licensees”) to also benefit from the use of the IRP.

3. How much does it cost?

As expected, with such a targeted assessment by the MHRA, in which the expertise and decision-making of trusted regulatory partners is considered, one would assume not only the timeframes to be reduced but also the application fees. The table details the price differentials as compared with a standard national procedure in the UK.

The IRP can also be used for line extensions, variations (Type IB, Type II) and renewals and the full fees schedule is published by the MHRA.

4. What to consider for Applicants?

The industry will surely welcome new regulatory pathways to MA approvals, especially those providing accelerated timetables and reduced fees. The IRP will be advantageous for developers with products already approved in other jurisdictions and the wider list of acceptable RRs expands the potential opportunities.

However, the perceived benefit for companies with innovative products are less apparent when considering the extensive Recognition B criteria, which mandates not only the longer approval pathway but also the process involving a clock stop (unlike the previous ECDRP), potential CHM consultation and risks of defaulting to the 210-day procedure, all of which reduce the attractiveness of this new regulatory approach.

Also to bear in mind that the MHRA is sovereign and retains the authority to reject applications if the evidence provided is considered ‘insufficiently robust’; approval of the same product by a RR does not guarantee a UK MA.

That said, it is notable that the UK authority has recently approved its 1st IRP MAA in 30 days for Amgen’s bone cancer drug Xgeva (denosumab), which was a line extension (same dose; higher concentration) for the new formulation in a prefilled syringe. The Committee for Medicinal Products for Human Use (CHMP), within the European Medicines Agency (EMA) issued its positive opinion on 25th January 2024; the MHRA accepted this assessment and approved the drug on 29th January 2024.

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