The Clinical Trials Regulation (EU) No 536/2014 (the "Regulation") came into effect in the EU on 31 January 2022, repealing the Clinical Trials Directive 2001/20/EC (the "Directive"). The aim of the Regulation is to streamline and harmonise the procedures for assessment and supervision of clinical trials throughout the EU. The changes introduced by the Regulation include an authorisation procedure based on a single submission via an EU portal, a new assessment procedure leading to a single decision on a clinical trial, and enhanced transparency requirements.
Transition Period Ends on 31 January 2023
A transition period of one year ran from 31 January 2022, during which sponsors of clinical trials could elect between submitting an initial clinical trial application under the old system of the Directive or according to the Regulation. This one-year transition period will come to an end on 31 January 2023. From this date, all initial clinical trial applications must be submitted under the Regulation, via the new single EU portal called the Clinical Trials Information System ("CT Information System"). The introduction of the CT Information System means that all sponsors will use the same system and follow the same process for the authorisation of a clinical trial.
New Clinical Trials Information System
CT Information System was created by the Regulation to act as the single EU entry point for submitting clinical trial information and as a clinical trial database. Sponsors, Member States, the European Commission and the public have access to different aspects of the system, which comprises of two workspaces with restricted access for sponsors and authorities and a public website. The European Medicines Agency ("EMA") manages the information stored in the database.
The Regulation introduces a new two-part assessment procedure for all clinical trials. Part I involves a scientific assessment of the core clinical trial documentation, and Part II involves an ethical assessment of documentation at national level. Following this two-part assessment, each member state will reach a single decision on the trial and notify the sponsor via CT Information System.
For ongoing trials previously authorised under the Directive, sponsors are permitted to submit substantial amendments under the Directive until the end of the transition period on 30 January 2025. All trials authorised under the Directive must end or transition to the scheme under the Regulation by 31 January 2025.
The EMA is delivering an online modular training programme to assist parties in their preparation for using the CT Information System. The programme covers the full life cycle of a clinical trial through submission, authorisation and supervision, and also covers the preparatory steps needed to use CT Information System, such as user registration.
One of the key aims of the Regulation is to increase the transparency of clinical trial activity in the EU. The CT Information System assists this objective by making clinical trial information accessible to the public. Since 31 January 2022, anybody can use the CT Information System website to view information on trials in the EU and EEA. The database will grow from 31 January 2023, when all initial clinical trial applications will be submitted via the CT Information System.
With the introduction of the CT Information System, as the single EU portal and database, and the model Clinical Trial Agreement (see our previous article: Life Sciences Update: New Agreement on Medicine Pricing and Model Clinical Trial Agreements in Ireland) we expect to see improved efficiency and an increase in the number of clinical trials carried out in Ireland.