Denmark Lakemiddel News

New CTIS Module Functionalities for Non-Substantial Modifications

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.

Guidance on Investigator Brochure Content for ATMP Clinical Trials

The Danish Medicines Agency has published guidance on the required content of the Investigator's Brochure for clinical trials involving Advanced Therapy Medicinal Products (ATMPs). The guidance integrates the ICH GCP IB format description with ATMP-specific recommendations from the EMA guideline on ATMPs in clinical trials. Sponsors and clinical investigators conducting ATMP trials should review the guidance and ensure their Investigator's Brochures align with these requirements.

PRAC Concludes NAION Is Very Rare Side Effect of Ozempic, Rybelsus, Wegovy

PRAC completed its safety assessment concluding that NAION (non-arteritic anterior ischemic optic neuropathy) is a very rare side effect of semaglutide medicines. Product information for Ozempic, Rybelsus, and Wegovy was updated on 30 September 2025 to include this finding. The frequency classification of 'very rare' means the side effect may affect fewer than 1 in 10,000 people. As of May 2025, the Danish Medicines Agency had received 28 reports of NAION in patients treated with semaglutide; by October 2025, this had risen to 32 Danish reports (14 Ozempic, 17 Wegovy, 1 both Ozempic and Rybelsus).