The highly anticipated EMA announcement was issued a few days ago: its new Clinical Trials Information System (the CTIS) meets its functional specifications. The EMA intends for the CTIS to go “live” on 31 January 2022 – after various delays and several years after the planned timeframe.

The CTIS has been the missing piece of the puzzle for the overhaul of the EU’s new clinical trial regime. This is because the Clinical Trial Regulation 536/2014 (the Regulation) will only apply once CTIS is operational. This means that the Regulation will apply on the same date that the CTIS goes live.

It remains to be seen, however, if the CTIS will work perfectly from day one. Almost all governments who have attempted to develop large scale IT systems to date have suffered problems of some degree and therefore it has to be hoped that CTIS does not fall into this category. Only time will tell.

The Regulation

Briefly, the Regulation will repeal the existing Clinical Trials Directive 2001/20/EC and apply directly in EU Member States. It will replace the existing system – in which national rules for the assessment and conduct of clinical trials vary – with a regime that is largely harmonised across the EU.

CTIS

A key element of the Regulation is the CTIS, a portal designed to facilitate communication and cooperation between EU Member States and provide members of the public with enhanced access to information about clinical trials.

The CTIS will also enable a crucial feature of the new harmonised regime introduced by the Regulation – a single authorisation procedure. In contrast from the current scenario, where applications must be submitted to multiple Member States simultaneously, the Regulation will mandate submission of one application dossier to all relevant Member States via the CTIS.

Additionally, the CTIS will enhance transparency of clinical trial data. All data contained in CTIS will be publicly available, with the exception of personal data, commercially confidential data, commercial communications between Member States and information about clinical trial applications that have not yet been approved. This means that members of the public will have access to almost all information submitted to the CTIS, including, for instance, a summary of the results of clinical trials.

Next steps

The European Commission will now consider whether the conditions set out in the Regulation are met – that is, whether the CTIS has achieved full functionality. If satisfied that this is the case, the Commission will publish a notice in the Official Journal of the European Union, and the six-month count down to the “go live” date will begin. Fingers crossed.