The eCTD format
The electronic Common Technical Document (eCTD) is a standardised format for submitting regulatory information to health authorities. Originally implemented using index files based on Extensible Markup Language (XML) and PDF documents, the eCTD streamlines the electronic submission of dossiers, ensuring consistency and efficiency in regulatory processes.
In Europe, the eCTD format is mandatory since 2019 for all regulatory submissions, whether initial marketing authorisation (MA) applications or variations for centralised, decentralised and national procedures.
Changes introduced by eCTD v4.0
The introduction of eCTD v4.0 (the latest version of the eCTD format) marks a significant step towards a more harmonised and efficient electronic submission environment, offering optimised metadata structures, improved lifecycle management and enhanced interoperability with global regulatory authorities.
Developed by the ICH, the eCTD facilitates the structured submission of data required for the MA of new medicines and the management of regulatory information throughout the medicine’s lifecycle. This latest version will replace the previous version (eCTD 3.2.2) and offer improved features and capabilities.
The four main benefits offered by eCTD v4.0, as reported by publishers of regulatory submission software, are as follows:
| #1 | Enhanced lifecycle management features | eCTD v4.0 promotes a more comprehensive approach to lifecycle management, as it allows for greater flexibility in managing content changes. |
| #2 | Easy correction of metadata | In eCTD v4.0, keywords play a key role in organising similar information, such as details on products, substances and manufacturers. They make it easy to correct typos, which simplifies the updating process and ensures the accuracy of eCTD submissions whenever changes to the metadata are required. |
| #3 | Greater flexibility | eCTD v4.0 allows for more flexible updates to the structure of submissions. These updates are managed via controlled vocabularies. |
| #4 | The reuse of documents | eCTD v4.0 allows a document to be submitted to a regulatory authority just once, referring to its unique identifier (UUID) with subsequent submissions (within the same application or across different applications). This streamlines both the creation and revision of submissions. |
To be noted: working documents relating to eCTD sections are not subject to the rules of eCTD v4.0 and must always be submitted “outside” the eCTD folder.
The implications of eCTD v4.0 for industry and health authorities
For industry and health authorities, the benefits of eCTD v4.0 are as follows:
> It provides internationally harmonised rules for creating and managing electronic submissions, without requiring specific software development for the EU.
> It simplifies dossier lifecycle activities, including the addition of new requirements or the adjustment of content granularity.
> It allows documents already submitted in other procedures (worksharing, PSUR, DCP/MRP) to be reused.
> It allows content already submitted to continue to be used via a single transition message.
> It facilitates better support for the automation of administrative processing.
> It reduces the maintenance of tools for managing and reviewing submissions, and facilitates future support for other types of regulated products (medical devices, clinical trials, veterinary products).
> It can indicate whether content has already been assessed by an agency and the outcome of that assessment, which can avoid additional reviews.
Furthermore, it will be possible to transfer the current content from version v3.2.2 to version v4.0 and continue the eCTD lifecycle in version v4.0.
In summary, significant time savings are expected with the implementation of eCTD v4.0 for all stakeholders.
The entry into force of eCTD 4.0 in Europe
Following the launch of pilot phases starting in 2024, followed by the optional use of eCTD v4.0 for medicinal products authorised under the centralised procedure (CP) only from December 2025, a phased implementation of eCTD v4.0 is planned in Europe as follows:
> 2026: optional use of eCTD v4.0 for medicines authorised under the decentralised procedure (DCP)/mutual recognition procedure (MRP)/national procedure (NP).
> 2027: mandatory use of eCTD v4.0 for medicines authorised under the centralised procedure (CP).
> To be determined: mandatory use of eCTD v4.0 for medicines authorised under the decentralised procedure (DCP)/mutual recognition procedure (MRP)/national procedure (NP).
To prepare for the future, minimise disruption to the management of their product lifecycle and maximise their competitive advantages, the regulatory affairs departments of pharmaceutical companies are strongly encouraged to undergo training on eCTD 4.0 as soon as possible.
ATESSIA’s consultants support pharmaceutical companies with developments relating to the formatting of electronic dossiers.
Article written by Isabelle MOUVAULT
Sources:
– eSubmission – eCTD v4.0 – march 2026 – eSubmission: Projects
– eSubmission – Business View on eCTD v4.0 – november 2018
– Electronic Common Technical Document (eCTD) v4.0 – EU Practical Document v1 – december 2025
– Lorenz eCTD 4.0 – eCTD 4.0 – The Next Evolution in Regulatory Submissions – march 2026
– ICH M8 – M8 eCTD v4.0 Electronic Common Technical Document (eCTD) v4.0 – ESTRI page for eCTD v4.0