The Common Technical Document (CTD) describes the organisation of modules, sections and documents to be used by an Applicant for a Marketing Authorisation for a medicinal product for human use agreed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator. While the table of content is consistent with the harmonised CTD, the eCTD also provides a harmonised technical solution to implementing the CTD electronically. In other words, an eCTD is the submission of PDF documents, stored in the eCTD directory structure, accessed through the XML backbone and with the files integrity guaranteed by the MD5 Checksum.
The current version of the eCTD specification to be used for CTD modules 2-5 is the Electronic Common Technical Document Specification V3.2.2 (PDF). More information about the standard can be found at the ICH eCTD webpage.
For eCTD submissions within EU, the EU Module 1 eCTD Specification (see link below) should be used.
The 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 accordance with the eSubmission Roadmap, Mandatory eCTD format is also stepwise introduced for National Procedures.
NeeS has been used as a transitional format towards the mandatory use of eCTD and is now only accepted in some specific cases.
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.