# Electronic Common Technical Document (eCTD) submissions update

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/824fb168-cd2d-4b9b-a81d-85336661ded9
Type: Detailed Guide
Published: June 16, 2025

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) has implemented stricter validation standards for electronic Common Technical Document (eCTD) submissions to ensure alignment with International Conference on Harmonisation (ICH) specifications. The agency identified that many existing dossiers lack necessary historical data, which triggers error messages in their new RegulatoryConnect system when documents are updated. The main issue involves incomplete historical sequences that prevent the system from accurately tracking document changes. Under this regulatory framework, any submission containing these technical discrepancies will remain stalled in the validation phase until the errors are corrected. To resolve these issues, affected companies are required to submit missing historical sequences to bring their electronic dossiers up to current ICH standards. The MHRA will proactively reach out to companies to identify missing records and suggest a timeline for completion, though companies may negotiate these deadlines if they are unrealistic. This mandatory cleanup of historical data is a prerequisite for launching future digital services, including instant automated technical validation and self-notification features. By ensuring data integrity now, the MHRA aims to facilitate faster, more automated approval processes in the future.

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## Content

Stricter validation criteria To improve the quality of submissions, the MHRA now requires stricter adherence to eCTD specifications. In accordance with the ICH (International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use) specification, historical sequences are required when you include a change to a document in your dossier, which is not held in our historic database. When this occurs the MHRA will receive an error message. The move to the new system has already identified some existing sequences with this issue. This problem may also occur with current submissions. In either case, we will contact you. Rectifying historical sequences issues To resolve this, companies must send us their historical sequences, and/or the additional sequences missing from our records as indicated in the error message. The MHRA will proactively contact companies facing this issue. The MHRA does not have the capability to rectify this situation. Companies must update the affected eCTD dossier to meet ICH standards. This effort will lay the foundation for future RegulatoryConnect features, including instant automated technical validation, auto-approval and self-notification. Validation phase Submissions with issues will remain in validation phase until resolved. The MHRA will suggest a timescale for fixing the issue, but companies can contact us if you feel the proposed timescale is unrealistic.