News about clinical trials
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Guidance on Complex Clinical Trials and Seasonal Vaccine Trials
| 02 October 2026 |
Please find below separate guidance on complex clinical trials and clinical trials involving seasonal vaccines.
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New Safety Module in the Clinical Trials Information System (CTIS)
| 23 September 2026 |
A new Safety Module in the Clinical Trials Information System (CTIS) will go live on 28 September 2026, followed by a two-month transition period ending on 30 November 2026.
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Are you working with the non-clinical package for clinical trial applications? See Q&A-update!
| 11 September 2026 |
Improved overview of GLP status for pivotal animal studies across all stages of drug development
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The guidance on digital and decentralised clinical trials (DCT) has been updated
| 09 June 2026 |
The update aligns with the common EU guidance and includes supplementary information relevant to the Danish context, including a section on cross-border participation.
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Remember to monitor deadlines in CTIS during the summer period
| 20 May 2026 |
As the summer season approaches, we would like to draw your attention to the need for forward planning in connection with the holiday period. All case processing will continue as usual in CTIS. However, please note that Denmark’s initiative for expedited processing of Phase I and integrated Phase I/II trials will not be available during weeks 29–31, 2026. Please read more here.
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For Clinical Trials with ATMP: Guidance to the content of the Investigator´s Brochure published
| 06 March 2026 |
See the Danish Medicines Agency’s guidance on the content of the Investigator’s Brochure for clinical trials with ATMPs
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New functionalities in the CTIS-module Non-substantial modification
| 09 February 2026 |
It is now possible to submit non-substantial modifications, where it earlier required submission of a substantial modification. It includes amongst others the prolongation of the clinical trial duration. See the full list of functionalities below and on our homepage.