2025
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Remember to Enter Start Dates in CTIS
| 19 February 2025 |
This is a technical necessity to ensure that the trial, and thus the approval, does not expire.
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Live streaming of the Danish Medicines Agency's after-work meetings on the revised ICH GCP guideline (ICH E6 R3)
| 13 February 2025 |
The Danish Medicines Agency will hold after-work meetings on the revised ICH GCP guideline (ICH E6 R3) on February 27 and 28, 2025, from 14:30 to 18:00. The meetings will be conducted by ICH E6 R3 EWG member and GCP inspector Lisbeth Bregnhøj. You can find the links for streaming in this news.
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New Protocol Template for Clinical Trials
| 06 February 2025 |
We have updated our protocol template to include even more guidance from both the Danish Research Ethics Committees and the Danish Medicines Agency. By starting out from this improved protocol template it can to a higher degree be assured that the regulatory demands to the protocol are met – and hopefully the process of developing the protocol is made easier and better.
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ICH GCP training – what are the expectations?
| 23 January 2025 |
ICH E6 revision 3 has now been published. The Danish Medicines Agency anticipate questions regarding the need for training and retraining and therefore publish this Q&A.
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Pharmaceutical companies must ensure that the labelling on the medicine packages cannot disappear
| 22 January 2025 |
When patients take medicine home, it is important that the text on the package does not fade or rub off when the patient have the package in their hands. The Danish Medicines Agency continu-ously tests whether the printed text meets the requirement that the labelling must be indelible. Find the Danish Medicines Agency's test method here.
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EU one step closer to electronic product information
| 16 January 2025 |
In 2023-2024, the Danish Medicines Agency participated in a pilot set to pave the way for using electronic product information (ePI) in favour of the printed package leaflets provided in the medicine package and the printed product information for healthcare professionals.
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Updating of summaries of product characteristics due to changed ATC codes for 2025
| 02 January 2025 |
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 2025.
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Fra 1. september 2025 vil Lægemiddelstyrelsen anmode om at modtage bioækvivalensdata i CDISC-format
From September 1, 2025 the Danish Medicines Agency will request submission of bioequivalence data in CDISC format Based on a pilot study conducted by the Danish Medicines Agency during 2023 an