eCTD: electronic Common Technical Document
The electronic Common Technical Document (eCTD) is the electronic format for regulatory dossiers, organised in the five-module structure defined by ICH M4.
In the EU, eCTD is required for centralised, decentralised and mutual recognition procedures and for most national submissions, with Module 1 following the EU regional specification. Each submission is a sequence that adds, replaces or deletes documents in the dossier's life cycle.
What goes wrong: incorrect lifecycle operations that leave obsolete documents current, inconsistent granularity between sequences, broken hyperlinks, and technical validation failures that delay the start of a procedure. A baseline submission helps when a legacy paper or NeeS dossier is converted.
Used in
Before compiling a sequence, check where a document belongs in the dossier and what the authority expects in Workbench, which answers with cited sources.
Related terms
- DCP: decentralised procedureThe decentralised procedure (DCP) authorises a medicine in several EU/EEA Member States at once when it is not yet authorised in any of them.
- Type II variation: major change requiring prior approvalA Type II variation is a major change that may significantly affect a medicine's quality, safety or efficacy and needs approval before implementation.
- CESP: Common European Submission PortalThe Common European Submission Portal (CESP) is the HMA platform through which applicants send dossiers electronically to EU/EEA national authorities.
- eAF: electronic application formThe electronic application form (eAF) is the mandatory EU form for marketing authorisation, variation and renewal applications in every procedure type.
- PLM Portal: EMA product lifecycle management portalThe PLM Portal is EMA's product lifecycle management platform for electronic application forms and eSubmissions for centrally authorised products.
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