eCTD (electronic Common Technical Document)

The requirement for using eCTD depends on the regulatory agency and type of submission. For the most up to date information, it is important to always consult the applicable health agency’s guidelines. In the EU, eCTD format is mandatory to use for all submission types related to Marketing Authorisation for products within all EU procedures (i.e. Centralised, Decentralised and Mutual Recognition Procedures). In the US, submission in eCTD format is required for certain INDs, NDAs, ANDAs and BLAs. In addition, other regions such as Canada, Switzerland, Japan, China, Australia, New Zealand and South Africa have implemented eCTD as optional or mandatory for certain types of submissions.

Yes, a specialized software tool is needed for compiling, publishing and validating an eCTD submission. Such software is commercially available. We use high-quality software that is routinely updated and validated to ensure compliance with the most recent requirements and validation criteria.

The main difference between NEES and eCTD is the way of navigating. In a NEES dossier, navigation occurs via a table of contents, hyperlinks and bookmarks. Although eCTD also contains hyperlinks and bookmarks, in addition it uses an xml backbone consisting of 2 xml files (an index and a regional xml file) that is used for navigating.

Also, there is no life cycle management for NEES dossiers. In an eCTD dossier, documents can be replaced or deleted in a new sequence. In a NEES dossier documents can only be newly added, and when a replace or delete action is to be performed, this should be explained to the regulatory agency in accompanying text.

A baseline is an eCTD sequence used to convert an existing paper or NEES dossier to eCTD format. It represents the current status of the registered dossier and serves as a starting point for dossier life cycle management of the eCTD dossier. It is not allowed to include any updates in the baseline, it should only contain previously submitted documents (with the exception of format changes). Submitting a baseline is usually beneficial for the transparency and regulatory compliance. However, please refer to specific guidance from regulatory agencies to determine whether a baseline is mandatory, optional or not accepted.

eCTD v4.0 will be the next upcoming major version of eCTD, replacing the current version 3.2.2. The implementation dates for the voluntary and mandatory use of eCTD v4.0 in the different regions can be found via the ICH website.

With the implementation of v4.0, new features and capabilities will be introduced. The most important new features consist of:

Re-use of documents: each document will be assigned a unique identifier code, by which a document can be referenced in a future submission.

Correction of previous information: errors in metadata can be corrected, for instance the manufacturer name.

Controlled vocabularies: more values with a list of allowed entries will be implemented. This enables streamlining communication between applicants and authorities.

Changed lifecycle operations: the append operation will be omitted. More flexibility will be included for the replace operation, as in eCTD v4.0 it will also be possible to replace multiple documents with one document or vice versa.

Context of use: Documents will be assigned a context of use label and keywords, by which their place in the eCTD structural hierarchy will be determined.

If you would like to know more about the transition to eCTD v4.0 or would like support with this, feel free to reach out to us.