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Frequently Asked Questions (FAQ) - Approval (Ethics / Orphan drug)
Please follow the EU regulations on IVD: http://www.namsa.com/blog/View/entryid/190/blogid/2/update-on-the-new-eu...
Yes it is necessary. The ethical approval will only be granted if the CT will be performed according to GCP.
You should mention the national Ethic regulations of the respective countries and state that you will perform your trials in accordance to those.