Comparing the UK International Recognition Procedure (IRP) and Australia's Comparable Overseas Regulator (COR) Pathway

Key procedural differences and considerations for global regulatory submissions

As regulatory authorities increasingly adopt reliance models to improve efficiency and reduce duplication of scientific review, pathways that enable the use of trusted international regulatory decisions are becoming an important component of global regulatory strategy. These mechanisms allow national regulators to leverage prior assessments while maintaining independent oversight of marketing authorisation decisions.

Two examples of such pathways are the International Recognition Procedure (IRP) implemented by the UK Medicines and Healthcare products Regulatory Agency and the Comparable Overseas Regulator (COR) pathway administered by Australia's Therapeutic Goods Administration.

Both procedures allow sponsors to submit marketing authorisation applications that rely on prior approvals issued by recognised reference authorities. While the underlying principle of regulatory reliance is shared, the procedural frameworks and submission requirements differ between the two jurisdictions.

This article provides an overview of the UK IRP and the Australian COR pathway, highlighting key procedural characteristics and considerations for sponsors planning global regulatory submissions.

The UK International Recognition Procedure (IRP)

The IRP was introduced by the MHRA to facilitate reliance on approvals issued by recognised international regulatory authorities. The procedure allows applicants to seek a UK marketing authorisation based on a prior approval from a designated Reference Regulator (RR).

Recognised reference regulators include the European Medicines Agency (EMA) and all EU Member State Competent Authorities of the EEA, Australia (TGA), Canada (Health Canada), Switzerland (SwissMedic), Singapore (Health Science Authority Singapore), Japan (Pharmaceuticals and Medical Devices Agency (PMDA)), and the United States (Food and Drug Administration (FDA)).

Eligibility and Routes

Not all applications approved by a RR will be eligible for the IRP.

Eligible for IRP:	Not eligible for IRP:
Chemical and biological new active substances and known active substances	Traditional herbal registrations
Generic applications	Homeopathic registrations
Hybrid applications	Bibliographic applications
Biosimilar applications
New fixed combination applications

IRP can also be utilised for line extensions, variations (Type IB and Type II) and renewal applications. It is advised that the same RR be used for IRP applications throughout the product lifecycle.

There are two IRP routes that can be used depending on eligibility criteria that is met.

Route A:	Route B:
RR approved the product within the last 2 years	RR has approved the product within the last 10 years
60 day procedure with no clock stop	110-day procedure with 1 clock stop at day 70
Open to applications that meet the criteria for IRP and do not meet any of the 23 Route B criteria	If major objections are outstanding at day 110, formal advice is sought from CHM and timetable reverts to 210 days national timeline

The Australian Comparable Overseas Regulator (COR) Pathway

The COR pathway is an established reliance mechanism used by the TGA to support the evaluation of prescription medicines that have already been approved by a recognised international authority. The intention is that the TGA will only need to evaluate data generated specifically for the Australian context.

As with the IRP, comparable regulators include the Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and Decentralised EU procedures, Canada (Health Canada), Switzerland (SwissMedic), Singapore (Health Science Authority Singapore), Japan (Pharmaceuticals and Medical Devices Agency (PMDA)), and the United States (Food and Drug Administration (FDA)).

Eligibility and Routes

COR applications can relate to all types of new prescription medicines, as listed below. However, not all applications approved by a comparable overseas regulator will be eligible for the COR.

Eligible for COR:	Not eligible for COR:
New Chemical Entities and New Biological Entities applications	Literature based submission (unlikely)
Generic applications	Any application delayed, deferred, rejected, or withdrawn at any time in any country
Biosimilar applications	Non-prescription medicines
New fixed dose combination applications	Provisional or conditional approvals
Extension of indications, new dosage forms, and changes to product information requiring evaluation of clinical data

Similar to the IRP, there are also two COR routes that can be used depending on eligibility criteria that is met.

COR A:	COR B:
Overseas approval from COR is less than 1 year old. COR assessment package is complete and unredacted	Overseas approval from COR is more than 1 year. COR assessment package is complete and unredacted
Evaluation and decision timeframe for COR A applications is 120 working days	Evaluation and decision timeframe for COR B applications is 175 working days
Aside from the label, PI and RMP (where required), no additional evaluation of Australian specific data is required	Additional data may be evaluated e.g. updated stability, validation data for additional manufacturing site and updates to pivotal studies that support the proposed indication
Identical formulation, strength and manufacturing process to that approved by COR	Differences allowed when approved via variations
GMP clearance for all sites approved	GMP clearance must be submitted but not approved

Overview of IRP vs COR

Although both pathways operate within the broader framework of regulatory reliance, there are procedural similarities and differences that sponsors should consider when planning submissions.

Feature	UK IRP	Australia COR
Regulatory authority	Medicines and Healthcare products Regulatory Agency	Therapeutic Goods Administration
Pathway type	International recognition / reliance procedure	Comparable Overseas Regulator reliance pathway
Reference regulators	Europe (EMA and all Member State Competent Authorities), Australia (TGA), Canada (Health Canada), Switzerland (SwissMedic), Singapore (HSA), Japan (PMDA), United States (FDA)	UK (MHRA), European Medicines Agency (EMA), EU decentralised procedures, Canada (Health Canada), Switzerland (SwissMedic), Singapore (HSA), Japan (PMDA), United States (FDA)
Pre-submission steps	Completion of eligibility form at least 6 weeks before planned submission – this requires submission for triage/notification in certain circumstances	For COR A, GMP clearance applications must be approved. Pre-submission meeting or correspondence may be required. Submit application for Australia Application for Approved Name (AAN) if required. Submit Pre-submission planning form (PPF). Registration of all excipients in the Australian Approved Ingredients List.
Reference Regulator approval	Prior approval from an eligible Reference Regulator within 2 years (Route A) or 10 years (Route B)	Prior approval from a Comparable Overseas Regulator within 1 year (COR A) or historical (COR B)
Eligibility requirements	Chemical and biological new active substances and known active substances; Generic applications; Hybrid applications; Biosimilar applications; New fixed combination applications	Chemical and biological new active substances and known active substances; Generic applications; Biosimilar applications; New fixed dose combination applications; EOI, new dosage forms and PI updates requiring clinical evaluation
Eligible legal status	All eligible prescription and non-prescription medicines	Prescription medicines only
Reference product requirements	Generic, hybrid or biosimilar applications must reference a suitable UK reference product as well as a suitable UK comparator product as per MHRA guidelines	Generic and biosimilar applications must reference the AU reference product or a bridging study (COR B only)
Dossier format	CTD including all reference regulator assessment documentation (including draft reports) and local Module 1 content	CTD including unredacted overseas evaluation reports and local Module 1 content
Timelines	60–110 days	COR A: 120 days; COR B: 175 days
Regulatory outcome	UK national marketing authorisation granted by MHRA	Inclusion in the Australian Register of Therapeutic Goods

Key Considerations for Sponsors

For pharmaceutical companies planning global regulatory strategies, reliance pathways such as IRP and COR can provide opportunities to optimise submission timelines and reduce duplication of regulatory review. However, several factors should be considered.

Alignment with RR approvals

Sponsors should ensure that the product intended for submission remains consistent with the RR approval, particularly with respect to formulation, manufacturing processes, and indications. Any differences or interpretation should be discussed with the agency in advance, for example through a pre-submission meeting.

Availability of regulatory documentation

Successful reliance submissions depend on access to comprehensive regulatory documentation, including assessment reports and approval correspondence, translated and unredacted. Early planning is essential to ensure that the required documentation can be obtained and submitted as part of the dossier. For example, where a Reference Regulator has not provided all unredacted iterations of assessment reports as detailed on the MHRA website, IRP may not be possible. This is also the case for TGA's COR process. Whilst the US FDA is accepted as a Comparable Overseas Regulator, Sponsors are currently unable to access the unredacted evaluation reports, making it impossible to support a COR application on the basis of a US FDA approved dossier.

Local regulatory requirements

Although both pathways rely on overseas assessments, national regulatory requirements still apply. Sponsors must ensure compliance with country-specific requirements, such as pharmacovigilance obligations, risk management plans, and product information requirements. Specialist advice from country experts such as regenold and Pharma To Market can help to ensure all requirements are met and applications progress smoothly.

Global submission sequencing

The timing of approvals from reference regulators may influence eligibility for reliance pathways. Sponsors should consider how reliance procedures such as IRP or COR fit within the broader global regulatory strategy and submission sequencing.

Contact our Regulatory Experts

If you are considering entering the Australian or UK market and think you may benefit from utilising the IRP or COR pathways, our regulatory specialists can support with eligibility checks and submission planning, reliance strategy development, pre-submission meetings, and preparation of the required regulatory documentation.

Please contact our team to discuss how we can support your regulatory strategy.

regenold United Kingdom: consultancy@regenold.co.uk
+44 (0)1271 314320

Pharma To Market Pty Ltd: info@pharmatomarket.com
+61 7 31229979