Proposal for HPRA and NREC Clinical Trial Fees: Financial Year 2022

Open for submissions from 13 September 2021

Submissions close on 8 October 2021

 

The National Office for Research Ethics Committees (NREC) in partnership with the Health Products Regulatory Authority (HPRA) invite submissions, observations and comments on proposed clinical trial fees to be implemented in 2022.

 

The objective of this public consultation process is to invite stakeholders to feed into the finalisation of fees for ethics assessment of clinical trials from next year.

 

As part of this process, a consultation document provides details of the proposed fees to be charged for clinical trial applications under the new Clinical Trial Regulation (CTR), due to come into effect in January 2022. The document summarises the outcome of our review of fees, sets out the current operating environment, service levels and activities, and details anticipated changes in service levels and activities from next year. Specifically, it outlines changes to the procedure for scientific and research ethics assessment of clinical trials on the back of the new regulation, explains the implications on fees, and provides a proposed payment schedule and fee breakdown for review.

 

How to get involved

NREC and the HPRA are inviting interested parties to submit comments or questions to inform the process. The consultation document is available below and replies are welcome from all stakeholders. To get involved, please email your observations or comments to feesconsultation@hpra.ie by 8 October 2021.

 

Public consultation document

Read the Proposal for HPRA and NREC Clinical Trial Fees – Financial Year 2022 here.

 

How responses will be used

Information shared by respondents will be used to inform the finalisation of fees charged for ethics assessment of clinical trials in 2022. Response documents will be published on the HPRA website and will provide a general overview of the comments received and the changes made to the proposal as a result.

 

 

 

 

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