This message was posted by a user wishing to remain anonymous
Hello,
We are a startup looking into the cost and feasibility of conducting our clinical trials in various regions. We were looking up clinical trial fees but the information was hard to find, particularly for Europe.
This is what we have so far. Can anyone with more experience comment on the missing items / correct anything that may be incorrect? If there is a comprehensive resource available with information on clinical application fees, please let me know!
Any help is much appreciated!
Thanks,
Anonymous
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Region
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Filing Strategy
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Regulatory Fees (for a single clinical/investigational application)
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US
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Investigational Device Exemption (IDE)
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No fee
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EU
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Clinical Trial Application (CTA)
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France (ANSM)
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?
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Germany (BfArM)
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?
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Ireland (HPRA)
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€4300 (as of Jan 2020)
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Italy
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€2229.60 (as of Oct 2020)
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Netherlands (IGJ)
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?
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UK (MHRA)
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£3820 for Class I, IIa, IIb (as of Aug 2020)
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Canada
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Investigational Trial Authorization (ITA)
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No fee
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Australia
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Clinical Trial Notification (CTN)
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AUS $380 (as of Nov 2020)
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New Zealand
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Clinical Trial Approval
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NZ $7500 (as of Jul 2019)
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Israel
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Clinical Trial Application
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$1000 (as of Jan 2006)
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