Notifications about clinical trials
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Clinical trial guidelines in public consultation
| 28 June 2016 |
As a result of the EU's new clinical trial regulation, the European Commission has submitted four guidelines for public consultation.
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New Danish act on clinical trials
| 25 May 2016 |
The Danish Parliament has adopted a new act on clinical trials of medicinal products, which means that new research ethics committees will be established. However, the act does not come into force until 2018.
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Form for notification of invoice details concerning clinical trials discontinued
| 23 February 2016 |
The Danish Medicines Agency has decided to discontinue the form for notification of invoice details concerning clinical trials. Instead, the cover letter should provide details of who we should send the invoice to and any comments you want us to state on the invoice.
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Access to results in EudraCT from 13 January
| 13 January 2016 |
When a clinical trial of medicinal products has ended, the trial results must be entered in the EudraCT database. The system has been unavailable for a period of time during which data could not be entered in the EudraCT database. The EMA now re-opens the database and results can be entered in EudraCT again.
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New clinical trial regulation under way
| 12 January 2016 |
New EU Clinical Trial Regulation has been postponed until 2018
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Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications
| 09 July 2013 |
The Voluntary Harmonisation Procedure is a 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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Combined studies with a clinical trial and a performance study: Sponsors now have the opportunity to apply for approval through a national coordinated application process
The Danish Medicines Agency, in collaboration with Danish Medical Research Ethics Committees, has developed a new guideline on a national coordinated application process for combined studies with a cl