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    CTD / eCTD

    CTD / eCTD dossier: structuring a compliant regulatory submission

    The CTD format, harmonised by the ICH and delivered electronically as eCTD, is the backbone of any medicinal product submission. A walkthrough of the 5 modules and key pitfalls.

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    The Common Technical Document (CTD) is the regulatory dossier format harmonised by the ICH (International Council for Harmonisation) and adopted by European, US and Japanese health authorities. Its electronic version, the eCTD, is now mandatory for every European centralised procedure. Structuring this dossier correctly drives acceptability, review speed and, ultimately, market access.

    1. The 5 CTD modules at a glance

    The CTD organises information across five modules; the first is regional (specific to each authority), while the other four are harmonised.

    • Module 1 — Regional administrative information (forms, SmPC, package leaflet, labelling).
    • Module 2 — Quality, non-clinical and clinical summaries (Quality Overall Summary, Nonclinical & Clinical Overviews).
    • Module 3 — Quality / CMC: active substance, finished product, control, stability.
    • Module 4 — Non-clinical study reports (pharmacology, toxicology).
    • Module 5 — Clinical study reports (efficacy, safety, pharmacokinetics).

    2. From paper CTD to eCTD: what changes

    The eCTD is not just a bundle of PDFs: it relies on a standardised XML tree (eCTD v4.0 backbone), a mandated file granularity and rigorous lifecycle management (new, replace, append, delete).

    Every sequence is cumulative: it must remain consistent with the full dossier history, otherwise it will be rejected during technical validation by the authority (EMA, FAMHP, national agencies).

    3. Common pitfalls to watch

    • Poorly controlled sequence numbering and lifecycle — the leading cause of technical rejection.
    • Under-documented Module 3: missing specification justifications, insufficient stability data.
    • Inconsistencies between SmPC (Module 1), summaries (Module 2) and clinical reports (Module 5).
    • Missing or broken hyperlinks and bookmarks in PDF documents.
    • eCTD validation not performed before submission (tools: EURS is Yours, eCTDmanager, etc.).

    4. Good preparation practices

    A successful submission is prepared early, from the development phase. This means aligning CMC, non-clinical, clinical and regulatory teams around a shared dossier plan and freezing document templates before drafting.

    A pre-submission meeting with the relevant authority (EMA scientific advice, FAMHP pre-submission meeting) helps secure the strategy and anticipate questions.

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