Registration and regulation

Registration dossiers and deficiency responses

CTD has five modules: Module 1 is region-specific and Modules 2–5 share a common organisation. Structure alone does not establish content acceptance or regional eCTD compatibility.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: The authority determines the applicable route, version and administrative documents.

View my progress Practise in the lab

Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

Identify the authority, application type and product status.
Map each deficiency to the original question and dossier location.
Specify evidence, action, owner and due date.
Check consistency of numbers, versions and cross-references.

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Registration dossiers and deficiency responses

Prepare your evidence before a decision

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