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07 December 2011 /Side effects and trials
Improved guidance on the definition of a clinical trial of medicinal products
The Danish Medicines Agency acknowledges that it is often difficult to find out whether or not a trial is to be classified as a clinical trial of medicinal products. We have therefore updated chapter 1 of our Guideline for applications for authorisation of clinical trials of medicinal products in humans and have also included some examples of what is not a clinical trial. Along with the update, we have published information that can help researchers find out whether a trial is a clinical trial of medicinal products or possibly a non-interventional study.
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02 November 2011 /Side effects and trials
Electronic reporting of SUSARs from other EU countries now possible
The Danish Medicines Agency can now receive electronic reports of suspected unexpected serious adverse reactions, also known as SUSARs, from trials in other EU countries. SUSARs that occur in other EU/EEA countries must be reported to the Danish Medicines Agency if the trials have the same protocol (EudraCT number) as in Denmark. The new opportunity of electronic submission applies to precisely these SUSARs.
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08 September 2011 /Side effects and trials
New English e-form for reporting of adverse reactions in clinical trials (SUSARs)
The Danish Medicines Agency now launches an e-form in English for reporting suspected unexpected serious adverse reactions in clinical trials (SUSARs). The e-form specifically targets researchers and small and medium-sized enterprises that for some reason cannot report via EudraVigilance.
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23 August 2011 /Side effects and trials
Commission guidance on adverse reactions from clinical trials (CT3) has been changed
The EU Commission has updated its guidance on adverse reactions arising from clinical trials, known as CT3. In future, CT3 will also include the previous Eudravigilance guidance - clinical trial module (CT4) - as well as the Q&A document regarding adverse reaction reports in clinical trials.
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11 July 2011 /Side effects and trials
Electronic clinical trial applications do not meet format requirements
A month ago, the Danish Medicines Agency announced that it is possible to submit clinical trial applications electronically, and we are happy to see that many have taken advantage of this possibility. Unfortunately, quite many of the applications do not comply with the requested format.
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11 July 2011 /Side effects and trials
New list clarifies requirements for amendments to clinical trials
The Danish Medicines Agency receives many questions regarding which amendments to clinical trials are to be notified to the Danish Medicines Agency, in particular because the European guideline CT 1 has been revised.
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24 June 2011 /Side effects and trials
Amendments to the guideline on clinical trials in humans
In the Danish Medicines Agency's Clinical Trials department we have reviewed approx. 30 research-initiated applications for authorisation to conduct medicinal product trials submitted in 2010. The review was conducted to assess the need for improved guidance.
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16 June 2011 /Side effects and trials
Guide to getting started in clinical research
The Danish Ministry of Interior and Health has published a guide to getting started in clinical research, which is intended to make it easier and more attractive to engage in clinical research in Denmark. The guide is in Danish, but an English version is under way, and will be posted here on this page as soon as it is available.
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10 May 2011 /Side effects and trials
The Danish Medicines Agency prefers clinical trial applications on CD-ROM or sent via Eudralink
In future, the Danish Medicines Agency will prefer to receive clinical trial applications on CD-ROM or online via Eudralink. This is because we have migrated to digital processing and consequently scan all incoming post, which is then distributed electronically internally.
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01 April 2011 /Side effects and trials
Public access to EU clinical trials register
The register will, in time, cover all clinical trials in the EU, Iceland, Norway and Liechtenstein. The register provides knowledge about purpose and content of the thousands of ongoing or completed trials in Europe.
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16 March 2011 /Side effects and trials
Solutions to problems with EudraCT version 8
After the upgrade to EudraCT version 8, the Danish Medicines Agency has received increasing reports of problems with making changes to already saved XML files. Please find solutions to the problems here.
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11 March 2011 /Side effects and trials
Changes in EudraCT version 8
With the update of EudraCT from version 7 to version 8, several changes have been made to the underlying structure.
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04 March 2011 /Side effects and trials
EudraCT portal unavailable 3 – 10 March 2011
The EudraCT website will be unavailable from Thursday 3 March 2011 to Thursday 10 March 2011 due to the rollout of EudraCT version 8.
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01 March 2011 /Side effects and trials
Consultation on the revision of the Clinical Trials Directive 2001/20/EC
The European Commission has submitted a document on the revision of the Directive 2001/20/EC on good clinical practice etc.
