eCTD v4.0 (Project Coordination, a Sprint Companion)

A second transition, while the reform is already under way.

eCTD v4.0 (ICH M8) replaces the current v3.2.2 format with a completely new technical foundation for electronic regulatory submissions — a system change that coincides with the EU Pharma Reform. WRPA does not handle the technical publishing implementation; it provides project coordination: clarifying requirements, aligning the timeline with the reform workload, and leading the interface with your internal team or publishing partner.

EMA (Centralised Procedure)

Optional since 22 Dec 2025

Centralised procedures can already switch to v4.0 voluntarily today.

FDA

Voluntary since Sep 2024

The FDA has been accepting eCTD v4.0 submissions for over a year already.

Mandatory (new applications)

From Q1 2028 (recommended from Q1 2027)

For newly filed centralised marketing authorisation applications (CP). The timeline for existing eCTD v3.2.2 lifecycles is still pending, subject to further testing and readiness assessments.

✓Cross-checking the v4.0 timeline against your ongoing reform roadmap
✓Requirements clarification and RFP support — the technical tool decision stays with your team or publishing partner
✓Project management of the rollout as the interface between RA, IT, and your publishing partner

Request an eCTD coordination conversation Try the eCTD tab in the Navigator →

This service is part of the offering at Weidlich Regulatory & Program Advisory — a companion to the Diagnostic Sprint.

Timeline

eCTD v4.0 transition: what applies when

Since December 2025
Voluntary use of eCTD v4.0 for new marketing authorisation applications in the centralised procedure (CP).
From Q1 2027
eCTD v4.0 strongly recommended for new CP applications; v3.2.2 remains acceptable.
From Q1 2028 (planned)
Mandatory for new CP marketing authorisation applications.

Existing v3.2.2 lifecycles and national procedures (MRP/DCP/NP) are subject to their own transition rules, which EMA and CMDh have yet to define. As of: November 2026.

Do I have to convert existing products to eCTD v4.0?

Not immediately. Based on the current status, the obligation from Q1 2028 applies to new centralised marketing authorisation applications. How existing v3.2.2 lifecycles will be transferred will be regulated separately. It still makes sense to review your portfolio, publishing tool and processes now.

What changes in practice with eCTD v4.0?

eCTD v4.0 is based on ICH M8 and HL7 RPS: documents become reusable, and metadata and controlled vocabularies replace parts of the previous folder logic. This affects publishing software, templates, roles and training.

How long does a transition project take?

That depends on portfolio size, tool vendor and internal resources. The Diagnostic Sprint clarifies exposure, gaps and a 90-day plan in two weeks.