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News on clinical trials
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03 May 2013
New version of the guidance document Voluntary Harmonisation Procedure for clinical trials
April saw the release of version 3 of the Voluntary Harmonisation Procedure (VHP), a voluntary procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.
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04 January 2013
Answers to questions about post-authorisation safety studies
We have updated our questions and answers about clinical trials with further details about the so-called post-authorisation safety studies (PASS studies).
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16 November 2012 | Updated 16 November 2012
21 December is final date for submission of clinical trial applications in 2012
The Danish Health and Medicines Authority is closed between Christmas and New Year. Therefore, applications for authorisation of clinical trials in 2012 must reach us by 21 December 2012. All applications that we receive after this date will be considered received on 2 January 2013.
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07 June 2012
Report on clinical trials of medicines in humans notified in 2011
The Danish Health and Medicines Authority has published an annual report on applications for clinical trials of medicines in humans.
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24 May 2012
European Commission publishes guideline concerning the quality of biological investigational medicinal products in clinical trials
The European Commission has published a guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.
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01 May 2012
Questions and answers from the Clinical Trial Facilitation Group on trial designs and DSUR
The Clinical Trial Facilitation Group (CTFG) has drawn up a Q&A document on specific trial designs and a document on Development Safety Update Report (DSUR). The CTFG was formed in 2004 by the Heads of Medicines Agencies (HMA), one of the purposes being to obtain a more uniform interpretation of the EU regulatory requirements.
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25 April 2012
Use of EU register facilitates publication of clinical research
Researchers who author articles based on clinical trial results can now avoid having to publish the same study in two different public registers. They can avoid double-registration because the EU Clinical Trials Register has now been recognised by the World Health Organization (WHO’s International Clinical Trials Registry Platform) as a so-called 'primary registry' like its US counterpart ClinicalTrials.gov.
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13 April 2012
Risk-adapted assessment of clinical trials of already marketed medicinal products
The Danish Health and Medicines Authority has looked into the possibility of assessing clinical trials of already marketed medicinal products based on risk adaptation. We now offer shorter assessment times for clinical trials where the risk involved for patients is not higher than the risk of exposing the trial participant to standard treatment.
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01 March 2012
EMA has updated its questions and answers about GCP
In certain types of trial designs, the investigator and patient do not know whether the patient receives a placebo drug (inactive substance) or a medicine containing an active substance. But in some situations, the investigator needs to know what the patient has been given, in which case it should be possible for the investigator to break the blinding. The new question from EMA deals with whether or not the investigator is to contact the sponsor before he or she breaks the blinding for a patient in a trial.
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07 December 2011
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
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
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
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
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
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
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
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
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
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
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.
