The team of Starodub Regulatory Experts always keeps up to date with latest updates in applicable guidelines and directives. We stay current with the latest developments in applicable guidelines and directives by actively monitoring industry publications and engaging in continuous professional education. That is also why our eCTD team recently joined the eCTD v4.0 Masterclasses, which consisted of 6 lessons in total.
In the upcoming years, version 4.0 will replace the currently valid eCTD version 3.2.2, but it depends on the region when this will be exactly. For example, a few regions have already started the voluntary implementation this year, but for the first regions to implement eCTD v4.0 on a mandatory basis, we will have to wait until 2026 (Canada and Japan).
As the introduction of eCTD 4.0 will have major impact, it is recommended that pharmaceutical companies are aware of and be prepared for the consequences it will have. For example, the language used currently will change with the update. Terminology as ‘Dossier’, ‘Regulatory Activity’ and ‘Sequence’ will change into ‘Application’, ‘Submission’ and ‘Submission Unit’, respectively. Also, the 4-digit number we currently use for sequences (e.g. 0001) will become a single digit number for, in the new terminology, a submission unit (e.g. 1). Additionally, new terminology such as Context of Use and Keywords will be introduced.
Apart from the vocabulary, new functions will be introduced such as updating of metadata (without the need to submit to your authority) and Document Re-Use by introducing a Universal Unique Identifier for documents. Furthermore, the fixed tree structure as we are used to now will change into a hierarchy which is much more flexible. As a consequence, the export structure does not reflect a tree structure anymore and therefore a Viewer license will be mandatory to be able to see the structure.
As you may understand, it goes beyond the scope of this article to elaborate further on all the implications eCTD v4.0 will have for the future. Please be aware that the upgrade will be a big challenge for all parties involved, vendors, agencies and organizations, with the goal to better facilitate the processing and review of electronic submissions between sponsor and regulators, as well as promoting better re-use of content.
If you want to know more about eCTD v4.0 and how you can prepare for the transition, feel free to contact us via our Contact page.