Dáil Éireann Debate, Wednesday - 19 June 2024
130. Deputy Eoin Ó Broin asked the Minister for Health to provide the legal and regulatory requirements to make the results of interventional clinical trials that are not a clinical trial of an investigational medicinal product (including medical device trials and non-drug trials) public and to provide the exact name and applicable article(s) of all relevant laws and regulations. [26364/24]
Amharc ar fhreagraThe exact nature of the question being asked is a little unclear, however in framing a general response on the publication of information pertaining to clinical trials, it should be noted that there are relevant obligations in place with respect to clinical trials authorised under the Clinical Trials Directive (CTD). It should also be noted that all trials authorised under the CTD must end or transition to the Clinical Trials Regulation (536/2014) by 31st January 2025. The Clinical Trials Regulation (CTR) came into effect in the EU on 31 January 2022.
