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Ireland's HPRA: Guide to Clinical Trial Applications

Recently in January, the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "HPRA Guide to Clinical Trial Applications" which provides a guide to help companies or researchers who want to conduct clinical trials in Ireland.

A clinical trial is a study that tests a new medical treatment or drug on people to see if it is safe and effective.

The HPRA's Guide to Clinical Trial Applications outlines the steps and requirements that must be followed when applying to conduct a clinical trial in Ireland.

This guide helps ensure that the trials are conducted in a safe and ethical manner, protecting the rights and well-being of the participants.

A trial may only be conducted or started if it meets the following requirements:

  • the ethics committee has issued a favourable opinion; -

  • the HPRA has granted an authorisation;

  • the sponsor, or legal representative of the sponsor, is established within the European Economic Area.

Substantial amendments to authorised clinical trials are required to be authorised by the HPRA and or the NREC, depending on the scope of the substantial amendment.

Applications for new/initial clinical trials must be submitted via CTIS from 31 January 2023 and these applications should not be submitted to the HPRA.


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