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Frequently Asked Questions (FAQ) - Approval (Ethics / Orphan drug)
You cannot start any project activity without ethics approval. Ethics approval is not required by the time you submit your proposal (even though you should add any relevant documentation that you already have in place), but is indispensable for the start of activities. If your project is selected for funding and your ethics approvals are not in place yet, you should start the procedure immediately. Once you obtain your ethics approvals, they have to be submitted to the EC.
If possible, try to address the issues that were raised and led to the rejection, so that you fully comply with the requirements of the Ethics Committee and file again. If it is clear that you cannot get approval for that center, you have to adjust your workplan and recruit from different centers. In any case you cannot start any project activity without ethics approval.
Please follow the EU regulations on IVD: http://www.namsa.com/blog/View/entryid/190/blogid/2/update-on-the-new-eu...
It is sufficient to describe how you are planning to deal with ethical concerns and what the status of your ethical approval process is. To emphasize the likeliness and to increase the credibility that the ethical approval will be granted for this trial, it is helpful to mention your experience with any similar Clinical Trials (e.g. on national level) and explaining that you received ethical approval for those.
Yes it is necessary. The ethical approval will only be granted if the CT will be performed according to GCP.
According to the European Commission’s website on Medicinal products for human use http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm and the respective document, http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_53..., the directive has been effective since April 2014.
You should mention the national Ethic regulations of the respective countries and state that you will perform your trials in accordance to those.
Approval needs to granted by EMA, but they offer a lot of assistance - contact them EARLY enough! The FDA approval might help as enabler/ door opener so you might receive Orphan drug designation earlier.