The Health Products Regulatory Authority (HPRA) Ireland has published a guide to a national pilot project to facilitate preparation for the implementation of the new clinical trial regulation (Regulation (EU) No. 536/2014). Sponsors are invited to participate in the project which will run until the implementation of the Regulation.
Currently the authorisation procedures for clinical trial applications and substantial amendment submissions at the HPRA and the ethics committees (ECs) are independent, under the present European Union (Directive 2001/20/EC) and national law (S.I.No.190 of 2004). This will change when the CTR is implemented, as one “single decision” per Member State will have to be provided through the EU portal.
An advantage for the sponsor is that they only need to submit the HPRA and EC documents to one location which is the HPRA, and if possible they 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.
To view the guide, please click here.