10/11 April 2024
Although the Clinical Trials Regulation EU No. 536/2014 (CTR) was adopted and entered into force in 2014, the timing of its application depends on the confirmation of the full functionality of the Clinical Trials Information System (CTIS - formerly the EU clinical trial portal and database) through an independent audit. The CTR becomes applicable six months after the European Commission (EC) publishes notice of this confirmation.
The EMA endorsed a timeframe in December 2015. However, due to technical difficulties with the development of the IT systems, the system's go-live date was postponed. In June 2019, the agency informed that the CTIS now enters a phase of agile, iterative delivery, to prepare the system for audit. It will then be further enhanced for go-live and beyond, in close cooperation with the user community. EMA has revised the CTIS project methodology and plan to improve delivery. Member States and stakeholders are now directly engaged in the development of CTIS through nominated ‘product owners’ to ensure that their expectations are taken into account. This means that business expert representatives have an enhanced and continuous opportunity to review, select and verify functionalities. In addition, the codes of the EU Clinical Trial Portal and Database and the safety reporting module have been merged and safety reporting functionalities have been developed. According to the agency, testing and key bug fixing took place in spring 2019. "CTIS is contributing to the global regulatory environment and is still a priority in EMA's Brexit preparedness business continuity plan", the agency says.
More information can be found on EMA´s Clinical Trial Regulation website.