Electronic Common Technical Document (eCTD)
The electronic specification for submitting a CTD dossier: the message standard, controlled vocabularies and validation criteria that make a submission machine-processable by a regulator. Version 4.0 is built on HL7 Version 3 Regulated Product Submission Release 2.
What this does not cover
stated in the document's own scope- It defines the electronic format, not the content of the dossier, which comes from M4 and the M4Q, M4S and M4E guidelines.
- It does not set regional acceptance dates; each authority does.
- Module 1 specifications are regional.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
ICH M8 is the topic that maintains the electronic Common Technical Document, the electronic format in which a CTD dossier is submitted to regulators. Its current major version, eCTD v4.0, is maintained as a set of Step 4 packages: an Implementation Guide package, a Controlled Vocabulary package and a Questions and Answers and Specification Change Request document. The older eCTD v3.2.2 is maintained alongside it. Regulators set their own dates for accepting and requiring v4.0.
Scope & applicability
The transport and structure of an electronic submission — how documents are packaged, identified, versioned and replaced across a product lifecycle. It does not govern content, which is M4. Regional Module 1 specifications sit alongside it and differ by authority.
Legal basis & how it acquires force
An ICH topic adopted in November 2011 and worked by an Expert and Implementation Working Group. Its documents acquire force when regulators adopt them in their electronic submission requirements. According to the M8 work plan of 10 February 2026, the eCTD v4 Implementation Guide Package v1.6 and Controlled Vocabulary Package v1.0 reached Step 4 in May 2024, the v4 Q&A document v1.9 in March 2025, and further updates were planned for 2026.
Document structure
| Part | Covers |
|---|---|
| eCTD v4 Implementation Guide Package | The technical specification and how to implement it; Step 4 version 1.6 in May 2024 |
| eCTD v4 Controlled Vocabulary Package | The controlled terms used in v4.0 submissions; Step 4 version 1.0 in May 2024 |
| eCTD v4 Questions and Answers and Specification Change Requests | Clarifications and agreed changes; version 1.9 in March 2025 |
| eCTD v3.2.2 maintenance | Valid values and Q&A for the earlier version, maintained in parallel |
Key requirements
- eCTD v4.0 Implementation Package — implementation guide and controlled vocabularies, versioned separately since May 2024
- HL7 V3 Regulated Product Submission Release 2 as the underlying message standard
- Lifecycle operations that let a document be replaced, appended or deleted across sequences without ambiguity
- Regional Module 1 specifications and validation criteria published by each authority
Implementation tips
- Rehearse technical validation before the real dispatch — publishing is treated as an administrative step at the end and then becomes the actual bottleneck
- Adoption is staged and regional: FDA began accepting eCTD v4.0 voluntarily in September 2024 with mandatory use projected later, so plan for both formats rather than one
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
M8 carries the content structure defined by ICH M4. Regional implementation guides specify Module 1 and regional requirements and set when each authority accepts or mandates v4.0. The M8 work plan records ongoing maintenance of the v4 packages as an approved ICH deliverable since December 2015.
ICH M8 (eCTD v4.0): frequently asked questions
Quick answers to common questions about ICH M8 (eCTD v4.0).
What is the difference between ICH M4 and ICH M8?
M4 defines the organisation of the Common Technical Document — what goes in which module. M8 defines the electronic format, eCTD, in which that dossier is submitted.
Which version of the eCTD v4 implementation guide is at Step 4?
According to the ICH M8 work plan of 10 February 2026, version 1.6 of the Implementation Guide Package reached Step 4 in May 2024, with version 1.7 planned for 2026.
Is eCTD v3.2.2 still maintained?
Yes. The M8 work plan includes continued maintenance of eCTD v3 questions and answers and valid values alongside v4.0.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.