MHRA - Electronic Common Technical Document (eCTD) submissions update

18th June 2025

MHRA - Electronic Common Technical Document (eCTD) submissions update

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.

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