International Recognition Procedure for fast-track approval of medicines

Recognition of decision-making by trusted regulators around the world can provide the twin advantages of avoiding duplication of effort, and accelerating the arrival of new products on the market, to the benefit of patients.

The UK’s International Recognition Procedure (IRP) will apply from 1 January 2024 for the purpose of accelerating the approval of new medicinal products, by allowing medicinal products approved in other countries to be fast-tracked for marketing authorisation in the UK, while retaining oversight and control. It will incorporate the current temporary EU recognition arrangements to offer a more comprehensive system.

UK regulator, the MHRA, has recently published detailed guidance on the IRP, which will be of interest to producers of medicines, and can inform their regulatory filing strategies.

From 1 January 2024 in Great Britain and from 1 January 2025 in Northern Ireland, the IRP will replace the current European Commission Decision Reliance Procedure (ECDRP) and incorporate the Mutual Recognition / Decentralised Reliance Procedure (MRDCRP), with any applications received by the MHRA before 31 December 2023 (31 December 2024 in NI) continuing under ECDRP/MRDCRP.

The IRP can be used by applicants established in the UK or EU/EEA. It will be open for applications for products which have already received authorisation from any of the following Reference Regulators -

• USA (Food and Drug Administration),
• the European Union (European Medicines Agency and national Competent Authorities),
• Australia (Therapeutic Goods Administration), Canada (Health Canada),
• Japan (Pharmaceuticals and Medical Devices Agency),
• Singapore (Health Science Authority Singapore) or
• Switzerland (Swiss Medic).

The IRP route will be available for a broad range of marketing authorisation applications, including:

• chemical and biological new active substances and known active substances;
• generic applications;
• hybrid applications;
• biosimilar applications; and
• new fixed combination product applications,

and also post-authorisation procedures such as line extensions, variations and renewals.

Note that the same Reference Regulator should be used for IRP applications throughout the product’s lifecycle.

A Recognition A 60-day timetable with no clock stop is available for most products approved by a foreign Reference Regulator in the previous two years. Certain features would move the product into the Recognition B 110 day timetable, with one clock stop at 70 days. These include for example:

• the foreign market authorisation is conditional or for exceptional circumstances;
• the applicant is seeking a conditional or exceptional circumstances MA in the UK;
• the product contains a first-in-class new active substance;
• the product incorporates novel or cutting-edge technologies.

Recognition A applications that have unresolved major objections after day 60 may revert to the Recognition B route.

If an application is determined not to be eligible for Recognition A or B, or if major objections are unresolved at the end of the 110 day timetable, may revert to the standard MHRA 210 day application timetable.

Six weeks before the intended submission date, the applicant should submit an online eligibility form to confirm suitability for Recognition Route A or B.

Applicants should note that other relevant regulatory requirements continue to apply, e.g. UK paediatric requirements or requirements relating to risk management plans or nitrosamine risk assessments.

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