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Børsgade Anne-Lucie sahmanonic Glumsø 4171 63096533 Lebara

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Glumsø 4171
63096533
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Change of practice for the Danish Medicines Agency’s inspections
The Danish Medicines Agency is now implementing the digital signing system called Penneo. As of 1 November 2022, we will be using digital signatures to sign all inspection reports.

2022 deadline for submitting applications concerning marketing authorisations and clinical trials
The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20th 2022. The Danish Medicines Agency is closed for the Holiday Season, from December 24th, 2022, until January 1st, 2023, both days included. Applications concerning marketing authorisations and clinical trials need to be submitted before December 20th, 2022. We will consider applications submitted after December 20th, 2022, as if they have been received January 2nd 2023.

Current Danish QRD template to be used in connection with the granting of marketing authorisations
Going forward, the current Danish QRD template is to be used for submissions of translations for new marketing authorisations under the mutual recognition procedure or the decentralised procedure as w

Invitation to EMA Organisation Management Service (OMS) Trouble Shooting Sessions for CTIS users
Before applying for clinical trials with investigational medicin products under the EU Clinical Trials Regulation no. 536/2014 (EU CTR), sponsors and trial sites have to be registered in EMAs Organizational Management Service (OMS). EMA is now inviting all sponsors and trial sites to online trouble shooting sessions, where they can submit questions in advance (see tabel below) concerning organisation and site registration in OMS.

Expression of interest for onsite participation in ACT EU workshop on Decentralised Clinical Trial guidance on October 4th 2022 – Response deadline is September 06th 2022.
New and innovative clinical trial designs and methodologiesprovide opportunities and challenges for the EU clinical trials environment. The EU decentralised clinical trials (EU DCT) project aims to address some of these challenges, in line with the European Medicines Agencies Network Strategy to 2025 and European Commission’s Pharmaceutical Strategy for Europe. Since March 2022, the Clinical Trials Coordination Group (CTCG) under the Heads of Medicines Agencies (HMA) have been responsible for the project management of the EU Decentralised Clinical Trials (EU DCT) project, with Ditte Zerlang Christensen of the Danish Medicines Agency (DKMA) as the project manager. The ACT EU Programme will host a multi-stakeholder workshop on DCTs on behalf of the EU DCT project, bringing together participants from all areas of the research community to share perspectives on this type of clinical trials. The multi-stakeholder workshop will be an onsite meeting hosted by EMA on October 4th 2022. A live broadcast of the workshop’s plenary session will be provided, open to all interested parties.

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