Electronic Common Technical Document (eCTD) 4.0
What is eCTD 4.0?
The Electronic Common Technical Document (eCTD) 4.0 is the latest standard developed by the International Council for Harmonisation (ICH) for submitting regulatory information electronically. It replaces eCTD version 3.2.2 with a more flexible, data-rich format that enables granular content updates, improved interoperability, and better lifecycle management across global regulatory agencies.
Unlike its predecessor, eCTD 4.0 adopts the HL7 Regulated Product Submission (RPS) message standard, making it possible to exchange structured content at the component level and link updates directly to impacted data without resubmitting entire dossiers.
Why it Matters in Pharma Today
- Granular content management — Agencies and sponsors can update individual sections or components rather than re-authoring complete submissions.
- Global regulatory alignment — Supported by ICH, FDA, EMA, PMDA, and other major agencies, ensuring a harmonised submission approach.
- Lifecycle efficiency — Improves tracking of submission history, variations, and regulatory queries over the product’s lifetime.
- Interoperability — Built on HL7 RPS, enabling tighter integration with internal authoring tools, regulatory databases, and agency systems.
- Future-proofing — Designed to support evolving regulatory requirements, structured data elements, and automation in submission assembly.
Global Landscape
| Region/Body | Governing Entity | Adoption Status / Timeline |
| ICH | ICH M8 EWG | Maintains eCTD 4.0 specification and implementation guidance. |
| European Union (EMA) | EMA | Implementation roadmap published; transition period from 3.2.2 in progress. |
| United States (FDA) | CDER & CBER | Draft guidance published; pilot submissions underway. Full adoption expected late 2020s. |
| Japan (PMDA) | MHLW/PMDA | Planning phase for migration from 3.2.2; no official go-live date yet. |
| Canada (Health Canada) | Health Canada | Monitoring ICH timelines; adoption likely post-EMA/FDA rollout. |
How eCTD 4.0 Works in a Component-Based Authoring Model
Author — Create regulatory content as structured, metadata-rich components aligned to eCTD headings and subheadings.
Assemble — Use metadata mapping to automatically place components into the correct eCTD sections.
Validate — Apply agency-specific and ICH M8 validation rules to ensure completeness and compliance.
Submit — Package and transmit via secure electronic gateways (e.g., FDA ESG, EMA Gateway).
Track — Monitor agency receipt, acknowledgement, and processing status; link feedback to specific components.
Update — Replace or amend only the affected component(s) without resubmitting the full dossier, enabling more efficient regulatory change management.
Typical Component Mapping in eCTD 4.0
- Module 1 (Regional Administrative Information) — MAH details, application forms, labeling.
- Module 2 (Summaries) — Quality Overall Summary (QOS), Nonclinical and Clinical Overviews.
- Module 3 (Quality) — CMC data, manufacturing sites, analytical procedures.
- Module 4 (Nonclinical Study Reports) — Pharmacology, toxicology.
- Module 5 (Clinical Study Reports) — Protocols, CSR, datasets.