European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. The Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC.

The Regulation strives for a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal [the Clinical Trials Information System (CTIS)], an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements. The Regulation also aims to facilitate the conduct of multinational clinical trials in the EU.

A 3-year transition period starts on the CTIS go-live date:

During the first year after CTIS go-live [from 31 January 2022 to 31 January 2023], sponsors will be able to choose whether to apply for a new clinical trial application (CTA) under the regime of the Clinical Trial Directive (CTD: Directive 2001/20/EC) including using EudraCT or to apply under the new legislation, the Clinical Trial Regulation (EU) No 536/2014, using CTIS.

During years 2 and 3 [from 31 January 2023 to 31 January 2025], the submission of new CTAs under the clinical trial directive will no longer be possible and, from the 31 January 2023 onwards, all new CTAs must be submitted under the new legislation (CTR) using CTIS.

By 31 January 2025, clinical trials authorised under the directive must either have ended in the EU/EEA or have been transitioned to the CTR framework.

The Clinical Trials Information System (CTIS) will act as the single entry point for clinical trials authorisation and supervision in the EEA. The exchange of information between sponsors and Member States and among Member States will be fully electronic within the CTIS system. This includes the clinical trial application dossier, requests for supplementary information, Annual Safety Reports, clinical trial amendments, corrective measures and other day-to-day business processes.

The clinical trial module of EudraVigilance will provide for the electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) by sponsors and re-routing to Member States.

CTIS is only accessible to registered users and an active EMA account is required to access CTIS.

For detailed information on the CTIS system including sponsor training and registration, please visit https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support

Further information can be found in the GUIDANCE NOTES ON CLINICAL TRIALS CONDUCTED UNDER THE CLINICAL TRIALS REGULATION (CTR) IN MALTA  - Feb 2024

Further queries may be sent by email to info.medicinesauthority@gov.mt and ccing postlicensing.medicinesauthority@gov.mt.