Notifications about clinical trials
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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