News 2026
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EMA’s Human Medicines Committee Recommends Wegovy in Tablet Form
| 22 May 2026 |
EMA’s human medicines committee (CHMP), part of the European Medicines Agency, decided at its meeting this week to recommend approval of Wegovy in tablet form. It is now for the European Commission to make the final decision.
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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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Operation Pangea XVIII: Global action against falsified medicines and illicit trade
| 07 May 2026 |
The Danish Medicines Agency has reported 6 websites to the police as part of the INTERPOL operation, Operation Pangea XVIII, and the Danish Customs Agency has detained 19 consignments containing illicit medicines, narcotics and doping substances.
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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.
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Electronic dispatch of decision letters marks its fifth anniversary
| 04 February 2026 |
Since 1 February 2021, the Danish Medicines Agency has been issuing decision letters on applications for marketing authorisations electronically and securely.
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Whistleblowing scheme of the Danish Medicines Agency from 1 January 2025 to 31 December 2025 (system of openness)
| 27 January 2026 |
The Danish Whistleblower Act obliges authorities that are subject to the rules of the Access to Public Administration Files Act to publish, at least once a year, information on the activities they have carried out under the Danish Whistleblower Act – a so-called system of openness (offentlighedsordning).
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Expedited Assessment of Clinical Trials in the EU: FAST‑EU Pilot Project Begins on 30 January 2026
| 23 January 2026 |
The sponsor guideline is now available.
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The GMDP-inspection focus for 2026
| 23 January 2026 |
Compliance with dossier requirements GMP inspections. In 2026, the Danish Medicines Agency will have a special focus on whether GMP companies comply with the requirements laid down in the dossiers o
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Updating of summaries of product characteristics due to changed ATC codes for 2026
| 05 January 2026 |
Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2026.