Clinical Trials Regulation – National Pilot Project

News Category: Regulatory news

Date: 14/12/2017

The HPRA has published a guide to the national Pilot Project which it has initiated in conjunction with the ethics committees to prepare for implementation of the Clinical Trials Regulation (EU) No.536(2014). Sponsors are invited to participate in the project which will run until the implementation of the Regulation. 

The main advantages for the sponsor are that they submit the HPRA and ethics committee documents to one location, the HPRA, and if feasible will receive a single national decision on the clinical trial.      

The guide explains the process in detail and will be updated as necessary throughout the period of the pilot project.   

For further information, visit the clinical trials section of our website or please contact

« Back