Applying to conduct a clinical trial: Fees

Costs
The requirement to provide payment of capital fees at the time of submission is a legal requirement specified in the MHRA Fees Regulations. Payment at a different time (eg on invoice) is not acceptable. Proof of payment must be clearly stated in the covering letter and/or as a separate document (eg photocopy of cheque / confirmation of bank transfer).

Guidance on how the applicable fees and how to pay is given below:

Type of trial	Fee payable from 1 April 2011
Phase I trial	£2,255
Phase II or Phase III patient trial with an unknown product	£4,244
Phase II or Phase III patient trial with an known product	£3,448
Phase IV trial	£265
Additional protocol* [same sponsor and same product (s)]	£265
Cross-referral	£265
Annual Service fee	£342

* For a cross-referral or additional protocol submission, no new IMPD or IB data should be provided; however, copies of the relevant manufacturer’s authorisation(s) and QP declaration (if applicable) should be provided since these are study specific.

Annual Service Fee (ASF): Note that in accordance with the periodic fees for marketing authorisations and licences regulations, all sponsors who hold open clinical trials authorisations (CTAs) on 1 April will receive an invoice for the service fee. This includes all trials which have been approved by the MHRA and for which we have not received an end of trial declaration and may include approved trials that have not yet started, have been temporarily halted or have ended but we have not yet been notified.

If you CTA is no longer active in the UK may wish to inform us of this so that your annual service fee can be stopped. Please refer to the Annual Service Fee page for details of how to inform us that a trial is no longer active in the UK.

It is not possible to provide exemptions and it is the responsibility of the sponsor to inform the MHRA if a trial has ended and the CTA is closed.

Payment options
The method of fee payment should be stated in the covering letter to the submission. Please be aware that failure to provide sufficient information on your electronic remittance to our bankers and/or not quoting the required bank details stipulated below may result in your payment being returned to you.

Please quote the EudraCT number, product name, protocol code and clinical trial authorisation (CTA) number (where available) when making payments for clinical trials.

Making a payment to the MHRA

Payment by bank transfer
Please refer to the 'Our bank account details' section of the website.

 

Please note; the Variation Deposit Scheme will no longer be available for payment of Clinical Trial Application fees. Any applications received after 31 January 2011 which use the Variation Deposit Scheme for payment of CTA fees will be rejected. For guidance on the acceptable forms of payment for CTAs please refer to the Fees pages on our website.

Contact for further information
For further information on paying fees, contact the Cashiers Department on 020 3080 6507 or by email to cashiers@mhra.gsi.gov.uk