News about clinical trials
| 30 August 2022 |
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.
| 25 August 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.
| 06 April 2022 |
The current situation in Ukraine can have an impact on the conduct of clinical trials. It can affect both the supply of trial-related drug products and the collection of critical data. Therefore, an initial guidance on the management of clinical trials in light of the situation have been issued by the European Commission (EC), the European Medicines Agency (EMA) and the Clinical Trials Facilitation and Coordination Group (CTCG).
The Danish Medicines Agency's guideline on extraordinary measures for clinical trials due to COVID-19 will not be extended after 01 December 2021
| 04 November 2021 |
We have chosen not to extend the validity of our guidance on extraordinary measures for clinical trials due to COVID-19 further, why the guidance and the granted exemptions expire on 01 December 2021.
Updated guidance on the implementation of decentralised elements in clinical trials with medicinal products
| 10 September 2021 |
You can now read the updated guidance on the implementation of decentralised elements in clinical trials with medicinal products - version 2.0
Guidance on the implementation of decentralised elements in clinical trials with medicinal products is now available
| 04 May 2021 |
Decentralised clinical trials with medicinal products meet the patients, wherever they are, in a faster and more efficient process benefitting both patient, healthcare professionals and industry. It is therefore gratifying to be able to announce that another important milestone has been reached in the Danish Medicines Agency's project to ensure an up-to-date and robust regulatory framework for decentralisation of clinical trials.
| 20 January 2021 |
In many cases, participating in a clinical trial is a considerable burden for the trial subjects. Clinical trials often involve many hospital appointments with a lot of travel and waiting time. The people who are affected the most live far away from the hospital departments concerned, with resulting unequal access to clinical research in Denmark.
| 20 January 2021 |
Participate in a clinical trial from the comfort of your own home. It may sound a little crazy, but it is actually possible in many respects. The Danish Medicines Agency has started a project to enable researchers and pharmaceutical companies to conduct so-called decentralised clinical trials which by means of new technologies make it easier for people to participate in clinical trials. It makes it more convenient for the participants and increases efficiency, while ultimately getting medicines to market faster for the benefit of patients.
| 23 November 2020 |
Please be informed that the gateway for SUSAR submission is now available again. If You after 48 hours have submissions that are pending acknowledgements, please contact the Danish Medicines Agency.
The Danish Medicines Agency cannot receive electronic adverse drug reactions via E2B in the period November 19th from 10:00 CET to November 24th
| 11 November 2020 |
Due to implementation of a new IT-system is it not possible for the Danish Medicines Agency to receive electronic adverse drug reactions (SUSARs) via E2B (DKMAEUDRA) in the period November 19th (10:00 CET) to November 24th 2020. Submissions to EVCTMPROD are not affected.
| 09 October 2020 |
UPDATED. We are aware that COVID-19 has consequences with regards to the conduct of clinical trials in Denmark. Multiple factors play a role such as trial participants in quarantine, limited access to public places (including hospitals) due to the risk of spreading infections etc.
| 06 October 2020 |
A fine or imprisonment of up to four months is the ultimate punishment if the results from clinical trials of medicines are not published. The Danish Medicines Agency will be taking a tougher line on investigators – the so-called sponsors of clinical trials of medicines – if they do not publish the results of the trials they carry out.
| 17 March 2020 |
Clinical trials investigating treatments for COVID-19 will be processed within 3 days. The processing time is extended if major objections is raised but we prioritise to have these solved immediately.
End of day meeting on new EU recommendations on complex clinical trials at the Danish Medicines Agency
| 29 March 2019 |
The Danish Medicines Agency invites pharmaceutical companies, researchers and other interested parties to an end of day meeting on the new European recommendations on complex clinical trials which aim to support the development of personalised medicine.
| 08 March 2019 |
The common European subgroup for complex clinical trials with trial subjects, which is headed by Denmark, has just published a set of recommendations for the development of personalised medicine.
| 20 September 2018 |
Medicines of the future is one of the topics being debated at the meeting of the World Economic Forum, which is currently place right now in Tianjin in China. The Danish Medicines Agency is attending.
| 11 July 2018 |
Fees are no longer charged for Phase I clinical trials and non-commercial clinical trials of medicines. This is the result of the Growth Plan for Life Science and the Budget for 2018. The new rules entered into force on 1 July 2018.
| 03 May 2018 |
The Danish government, the Danish People's Party and the Danish Social-Liberal Party have agreed to exempt commercial sponsors from all fees for phase I clinical trials of medicines. The government has previously decided – in connection with the Budget Bill 2018 – to remove the Danish Medicines Agency’s fees for non-commercial (research-initiated) clinical trials of medicines.
| 14 November 2017 |
In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.
| 13 June 2017 |
LLast year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.