Source

Danish Medicines Agency

3 documents · Denmark

Regulation Category Type Date

Q&A update: Non-clinical package for clinical trial applications – GLP status for pivotal animal studies

Updated Q&A guidance clarifying GLP status requirements for pivotal animal studies in clinical trial applications across all drug development stages.

Danish Medicines Agency · Denmark

Clinical Trials & ResearchPharmaceuticals

Guidance 11 Sep 2026

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New Safety Module in the Clinical Trials Information System (CTIS)

A new Safety Module in CTIS will launch on 28 September 2026, with a two-month transition period ending 30 November 2026.

Danish Medicines Agency · Denmark

Clinical Trials & Research

Administrative 23 Sep 2026 Due 28 Sep 2026

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Danish Medicines Agency ATMP Open House

Are you working with advanced therapies in Denmark? Join us on 23 October for an afternoon focused on the development and regulation of Advanced Therapy Medicinal Products (ATMPs).

Danish Medicines Agency · Denmark

Pharmaceuticals

News & press 10 Sep 2026

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Showing 3 of 3 tracked updates Health-tech only