New CTIS Module Functionalities for Non-Substantial Modifications
Summary
The Danish Medicines Agency (DKMA) announced new functionalities in the EU Clinical Trial Information System (CTIS) module for non-substantial modifications, effective 9 February 2026. Sponsors can now directly submit non-substantial modifications that previously required a separate non-substantial modification submission, including prolongation of clinical trial duration. Affected fields span Trial Information (Part I), Protocol documents, SA/PIP updates, Associated Clinical Trials, and Sponsor information — with restrictions on adding new PIPs, new co-sponsors, or ORG-ID changes.
“It is now possible to submit non-substantial modifications, where it earlier required submission of a non-substantial modification.”
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GovPing monitors Denmark Lakemiddel News for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 3 changes logged to date.
What changed
The Danish Medicines Agency has expanded CTIS portal capabilities to permit sponsors to submit non-substantial modifications — previously requiring a separate non-substantial modification application — directly within the module. New editable fields include Trial Information (medical condition, trial duration, source of support, age range, clinical trial group), Protocol documents (upload and update), SA additions/updates, PIP updates where a PIP already exists, Associated Clinical Trials management, and Sponsor contact-point changes. Restrictions apply: new PIPs cannot be added, co-sponsors cannot be added (only deleted), and ORG-ID sponsor changes are not permitted.
Sponsors of ongoing clinical trials authorised in Denmark should review the updated CTIS functionalities to determine whether current trial management processes can be streamlined. Trial sponsors should confirm that duration prolongations and other non-substantial changes are now captured in-module rather than via separate submissions. Queries should be directed to DKMA's clinical trials guidance resources.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
News / 2026 / New functionalities in the CTIS-module Non-substantial modification
New functionalities in the CTIS-module Non-substantial modification
09 February 2026
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It is now possible to submit non-substantial modifications, where it earlier required submission of a non-substantial modification. It includes amongst others the prolongation of the clinical trial duration. See the full list of functionalities on our homepage and below.
Tab MSCs:
- Trial subject numbers
Tab Part I:
- Trial information - following sections can be edited;
- Medical condition
- Trial duration
- Source of monetary support or material support
- Age range (minors cannot be added)
- Clinical trial group (Healthy, patients, vulnerable)
- Protocol
- All sections can be edited, new documents can be uploadet, existing documents can be opdated
- SA and PIP
- SA can be added/updated
- PIP can be updated, if there is an existing PIP, but no new PIP can be added
- Associated CTs
- Associated CTs can be added/deleted
- Document agreement from another sponsor, can be added/updated
- Sponsor
- Sponsorinformationer can be changed, as long as it in not ORG-ID
- Co-sponsor can be deleted, but not added
- Responsibilities can be changed
- Contact points can be added/changed
Named provisions
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Source document text, dates, docket IDs, and authority are extracted directly from DKMA.
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