With Brexit transforming the regulatory landscape in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has taken strategic steps to streamline drug approvals. One of the key post-Brexit regulatory pathways is the International Recognition Procedure (IRP), which allows faster approval of medicines already authorized by trusted reference regulators. 

To support this procedure, the MHRA has issued new guidance for eCTD submissions — aimed at standardizing how marketing authorisation applications (MAAs) and lifecycle updates should be structured and submitted. 

This blog outlines the core components of MHRA’s eCTD guidance for IRP, why it matters, and what global regulatory affairs teams need to prepare for. 

📄 Source:
Full guidance available on gov.uk – MHRA eCTD Guidance for IRP 

What Is the International Recognition Procedure (IRP)? 

The IRP is a UK-specific regulatory route that enables the MHRA to evaluate marketing applications based on assessments already performed by recognized reference regulators, including: 

• EMA (European Medicines Agency) 

• USFDA 

• Health Canada 

• Swissmedic 

• TGA (Australia) 

• HSA (Singapore) 

This procedure is designed to accelerate patient access to medicines in Great Britain by leveraging work already done by these trusted authorities. 

MHRA’s eCTD Requirements Under IRP 

The MHRA requires all initial MAAs and lifecycle submissions under IRP to be submitted in eCTD format. The guidance provides specific instructions for: 

✅ 1. Initial Submissions (MAAs) 

• Must follow the standard eCTD format in line with ICH and EU guidance. 

• Module 1 must comply with UK-specific requirements, including national application forms and Great Britain-specific information. 

• Submissions must be routed through the MHRA submissions portal, not via the EMA’s Common European Submission Portal (CESP). 

✅ 2. Lifecycle Submissions 

• Variations, renewals, and line extensions under IRP must also be submitted in eCTD. 

• A full eCTD lifecycle history must be maintained. 

• The sequence numbers and metadata should follow MHRA conventions (starting from sequence 0000 for new procedures). 

• Consolidated sequences are not accepted — every submission should contain only the documents relevant to the scope. 

✅ 3. Reference to Foreign Assessment Reports 

• If referring to an assessment report from a reference regulator (e.g., EMA or USFDA), it must be included in Module 1. 

• A summary of that report, along with a comparison to the UK product, may also be required. 

✅ 4. Technical Validation 

• All eCTD submissions must pass MHRA’s technical validation criteria, which are based on the EU Harmonised eCTD guidance but with specific national adaptations. 

Why This Matters for Global Regulatory Teams 

As the MHRA formalizes its post-Brexit regulatory independence, sponsors must now manage UK submissions as distinct from the EU — both in content and submission logistics. 

Here’s what this means for regulatory operations: 

Area	Impact
Submission Format	eCTD is mandatory — NeeS or paper not accepted for IRP
Submission Platform	Must use MHRA’s own portal — not CESP
Reference Assessments	Must be clearly identified and summarized in Module 1
Lifecycle Tracking	Full eCTD lifecycle required from initial sequence onward
Timeline Sensitivity	Clean, well-structured eCTDs reduce the risk of delays in IRP review

Best Practices for Compliance with MHRA IRP eCTD Guidance 

To align with the new requirements and ensure smooth submission outcomes: 

✔️ Use a validated eCTD authoring and publishing tool 

✔️ Apply UK-specific Module 1 content early in your submission planning 

✔️ Map your submission lifecycle and maintain proper sequence tracking 

✔️ Ensure technical validation before uploading to the MHRA portal 

✔️ Train your team on the MHRA IRP process and distinctions from EU centralized procedures 

Prepare Early for UK eCTD IRP Submissions 

MHRA’s eCTD guidance for the IRP is a key milestone in the UK’s independent regulatory framework. For global pharmaceutical companies, this means adapting to a UK-specific submission model, with distinct processes, lifecycle management, and formatting expectations. 

A proactive, region-specific approach is essential to avoid delays and ensure approval readiness.