UK MHRA Guidance: Electronic Common Technical Document (eCTD) Submissions Update

The Medicines and Healthcare products Regulatory Agency (MHRA) published a key update on 17 June 2025, outlining revised requirements for electronic Common Technical Document (eCTD) submissions. This update marks a significant milestone in the UK’s shift toward enhanced digital regulation via the Regulatory Connect Programme.

1. Key Aspects of the Update

Stricter Compliance with eCTD and ICH Standards

The MHRA now enforces tighter adherence to the ICH eCTD specification: all eCTD sequences—including historical ones—must comply fully. A validation error will occur if an organization’s submitted sequence deviates from MHRA’s database.

Requirement: Historical Sequence Restoration

To remedy sequence discrepancies, affected companies must resubmit missing or historical sequences flagged by MHRA via error notifications. Notably, the MHRA cannot rectify gaps internally—responsibility resides wholly with the submitting company.

Validation Phase & Timeline Impacts

Submissions with unresolved sequence errors enter a validation phase, during which MHRA may suggest deadlines to fix issues. Applicants can negotiate if deadlines appear unachievable. Until the errors are resolved, technical validation halts further progress through the system.

2. In-Depth Analysis & Industry Implications

Strategic Alignment with Regulatory Connect

This update supports MHRA’s broader ambition for Regulatory Connect—a platform promising real-time technical validation, partial auto-approval, and automated self-notification. The new requirements lay the groundwork for this digital ecosystem.

Digital Traceability & Lifecycle Integrity

Enforcing historical sequence integrity ensures that each eCTD lifecycle is auditable, traceable, and compliant with ICH version control standards. This echoes a global shift toward digital regulatory traceability, seen in EMA and FDA modernization initiatives.

Operational & Resource Considerations for Sponsors

• Legacy data risk: Submissions from older product lines may require retrieving archives or reconstitution of past sequences, which can prove resource-intensive.

• Validation delays: Technical errors delay submissions, affecting regulatory approval timelines and potentially product launches.

• Resource planning: Companies must plan dedicated teams to review, track, and rectify sequence issues, ensuring uninterrupted regulatory workflows.

3. Broader Trends & Context

• ICH harmonization: The UK continues to align with global eCTD specifications, maintaining credibility in international submissions.

• Digital workflow adoption: The push toward RegulatoryConnect reflects a rising trend of regulators deploying tech-driven platforms to streamline approval processes.

• Lifecycle management best practices: Maintaining sequence integrity is standard practice globally, reinforcing the importance of proper document version control.

In summary, the MHRA’s 17 June 2025 update reinforces the mandate for complete and precise eCTD submissions—across all sequences, past and present—to comply with ICH standards. The change aligns with global trends toward digital regulatory platforms and lifecycle transparency.

Pharmaceutical sponsors should:

1. Audit existing eCTD sequences against MHRA validation flags.

2. Compile and submit any missing historical data.

3. Implement internal process controls to prevent future sequence discrepancies.

For full details and official instructions, please refer to the original MHRA LINK.