EU clinical trial portal and database declared functional

Regulatory NewsRegulatory News | 21 April 2021 |  By 

The European Medicines Agency (EMA) announced that its long-delayed EU clinical trial portal and database are fully functional, paving the way for the launch of the EU Clinical Trial Information System (CTIS) and the application of the EU Clinical Trial Regulation early next year.
The CTIS was originally expected in September 2018; however, a series of delays have pushed back the launch date for the system, and the EU Clinical Trial Regulation it is intended to support, to 31 January 2022.
“EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information Systems (CTIS), is now fully functional and on track to go live by 31 January 2022,” EMA said.
The functionality of the portal and database were confirmed by the agency’s Management Board on Wednesday following a review of an independent audit of the new IT system.
“The implementation of the Clinical Trial Regulation and CTIS will increase efficiency in the registration, conduct and supervision of clinical trials in the EU, particularly those taking place in multiple Member States, while ensuring utmost transparency for the public. This is one of the most complex and ambitious IT developments carried out by EMA and we look forward to its go-live in early 2022,” said Christa Wirthumer-Hoche, chair of EMA’s Management Board.
EMA’s Management Board will now inform the European Commission of the outcome of the audit. From there, the Commission will need to confirm that the system meets the conditions of the Clinical Trial Regulation and publish a notice announcing the functionality of the CTIS in Official Journal of the European Union.
The CTIS will go live six months after the date of publication of the notice, triggering the application of the Clinical Trial Regulation. “It is the desire of the Board, EMA and the European Commission that the system goes live on 31 January 2022, which would imply that the Commission notice in the Official Journal would be published on 31 July 2021,” EMA said.
Once the CTIS is in place, it will serve as a single entry point for EU clinical trial applications and enable trial sponsors apply for a clinical trial in all European Economic Area (EEA) countries with one application. The system will also “facilitate recruitment of trial participants by allowing sponsors and researchers to easily expand trials to other EEA countries, and will allow sponsors, researchers and national competent authorities to collaborate across boarders for better results and knowledge-sharing,” EMA said.


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