Swissmedic has announced the next step in its transition to eCTD v4.0, confirming that the new electronic submission standard will be introduced through a pilot scheme between January and April 2027.
The pilot is intended to test both initial submissions and more complex follow-up submissions before broader implementation of the new standard.
eCTD v4.0 Implementation Moves into Pilot Phase
eCTD v4.0 is the upgraded version of the electronic Common Technical Document standard developed by the International Council for Harmonisation (ICH) for medicinal product authorisation applications.
Swissmedic currently operates on eCTD v3.2.2 and expects to complete the technical implementation of eCTD v4.0 by the end of 2026. The new standard is expected to go live during 2027 once pilot testing has been completed.
Two-Phase Pilot Structure
Swissmedic has divided the pilot into two phases.
Phase 1 — Initial Submissions
Phase 1 will focus on initial submissions in eCTD v4.0 format.
The objective is to verify that initial submissions are technically valid and correctly structured according to the new standard.
Phase 2 — Follow-Up Submissions
Phase 2 will focus on follow-up submissions.
This phase is intended to test:
lifecycle management;
more complex submission structures;
continued handling of regulatory activities under eCTD v4.0.
Swiss Implementation Guide v2.0 Is Mandatory for the Pilot
Swissmedic confirms that pilot submissions must be based on the Swiss Implementation Guide v2.0 package, published on 26 October 2026.
This package replaced the previously published version 1.1 and contains several updates and amendments.
What the v2.0 Package Includes
The Swiss Implementation Guide package contains:
Implementation Guide v2.0;
Controlled Vocabulary lists v2.0;
corresponding Genericode files;
Validation Criteria v2.0.
These documents define the technical requirements that companies should follow when preparing Swiss eCTD v4.0 submissions.
Pilot Open to Interested Companies
Swissmedic states that the pilot is open to all interested companies.
However, participants must be technically capable of creating submissions in both:
eCTD v3.2.2;
eCTD v4.0.
Companies must also be able to dedicate sufficient time and technical resources to perform test submissions in collaboration with Swissmedic.
Communication in German or English
Communication between Swissmedic and participating companies will take place in either German or English.
Application Deadline for Phase 1
Applications for Pilot Phase I can be submitted until 27 November 2026.
Interested companies are asked to provide:
contact person details;
the name of the publishing software used;
information on any previous experience with eCTD v4.0 submissions to other regulatory authorities.
Swissmedic will then select suitable participants.
Why the Pilot Matters
The pilot marks an important step in Swissmedic’s transition toward a more modern submission infrastructure.
The move to eCTD v4.0 is intended to improve international compatibility with other regulatory authorities and support more structured lifecycle management of regulatory submissions.
For pharmaceutical companies, the transition will require adjustments to:
publishing software;
internal submission workflows;
validation processes;
lifecycle management;
metadata handling;
regulatory operations procedures.
eCTD v3.2.2 Will Remain Supported
Swissmedic has confirmed that the current eCTD v3.2.2 standard will continue to be supported during a transitional period lasting several years.
This should provide companies with time to adapt their regulatory systems and submission infrastructure.
Impact on Regulatory Operations Teams
Companies planning to submit medicinal product applications in Switzerland should begin assessing their readiness for eCTD v4.0.
Key considerations include:
compatibility of publishing tools;
implementation of the Swiss Implementation Guide v2.0;
controlled vocabulary updates;
validation criteria;
lifecycle management processes;
training of regulatory operations teams.
Opportunity to Test Before Full Rollout
The pilot gives companies an opportunity to test eCTD v4.0 workflows directly with Swissmedic before wider deployment.
For organisations already preparing for eCTD v4.0 in other jurisdictions, participation may also provide useful experience in aligning Swiss requirements with broader international implementation.
