Understanding the International Recognition Procedure

The International Recognition Procedure (IRP) was introduced by the MHRA at the start of 2024. It replaced the EC Decision Reliance procedure and was created to speed up access to medicines in the UK. Instead of carrying out a full assessment alone, the MHRA can now draw on the work already completed by trusted regulatory partners – including Australia, Canada, Switzerland, Singapore, Japan, the United States, and the European Union and EEA. By building on approvals already granted elsewhere, the UK can bring treatments to patients more quickly while still maintaining high regulatory standards.

What the IRP Can Be Used For

The IRP covers a broad range of application types. It can be used for chemical and biological new active substances and known active substances, generic applications, hybrid applications, biosimilar applications, and new fixed combination products. Beyond initial marketing authorisation applications, companies can also use the IRP route for line extensions, Type IB and Type II variations, and renewals. It is generally recommended to keep the same reference regulator throughout a product's lifecycle to support continuity and alignment.

There are some exclusions, however. The IRP cannot be used for traditional herbal registrations, homeopathic registrations, or bibliographic applications.

Recognition Route A and Recognition Route B

There are two possible pathways within the IRP, each designed for different circumstances.

Route A

Route A is available when the reference regulator has approved the product within the last two years. It offers a 60-day timetable with no clock stop and is used when an application meets all IRP requirements and does not fall under any of the 23 conditions that would trigger Route B.

Route B

Route B can be used when the reference regulator approved the product within the last ten years. It follows a 110-day timetable and includes one clock stop at day 70. If major objections remain at day 110, the MHRA will seek advice from the Commission on Human Medicines and the timetable will shift to the standard 210-day national route.

Faster Timelines and Lower Costs

One of the major advantages of the IRP is the reduced review time. Even the longer Route B results in a decision in up to 110 days, compared with the 210-day national pathway. If outstanding issues cannot be resolved the assessment will fall back to the 210-day route, but for many applications the IRP significantly speeds things up. The route also offers important cost savings compared with the national procedure, making it attractive both financially and strategically.

Reduced Administrative Burden

Submitting via the IRP can streamline the preparation process. Modules 2 to 5 can largely be carried over from the reference regulator's dossier. Only Module 1 needs specific adaptation for UK requirements, which helps reduce administrative workload and resource needs.

Opportunities for Earlier UK Approval

A key benefit of the IRP is that it allows companies to use approvals from regulators outside the EU to gain earlier access to the UK market. This means a product may be approved in the UK before the EMA has completed its own review – something that was not possible under the previous ECDRP.

A recent example is ANKTIVA, which received UK approval on 4 July 2025 using the FDA as the reference regulator, while the EMA review remains ongoing. This demonstrates how the IRP can give companies a meaningful head start in the UK.

How regenold UK Can Help

If you would like to explore the IRP in more detail, or you're looking for support in planning or submitting an application, our regulatory specialists can help. We work closely with companies navigating the IRP and other UK procedures, offering practical guidance, strategic advice, and hands-on dossier support.