‘Bug’ Fixes Put EU’s Clinical Trials Website Back on Track for Jan. 31 Deadline
The deadline for mandatory use of the European Medicines Agency’s (EMA) Clinical Trials Information System (CTIS) remains Jan. 31 for EU sponsors and regulators following the agency’s success ironing out core software bugs that threatened to delay its official launch date.
The EMA reports significant progress on fixing technical issues within the system prior to the deadline. According to the agency, it has now taken care of more than 80 percent of “blocking bugs,” issues that keep other software bugs from being fixed.
With the agency on track to deliver the CTIS by the Jan. 31 deadline, sponsors and regulators will be required to switch over from EudraCT and begin using CTIS for all new trial applications on that date. Sponsors have had a year-long transitional period to get used to and test the system.
The system, a searchable website, allows sponsors to run trials in all of the trade bloc’s 27 member states through a single documentation filing. Through the website, sponsors are also able to submit updates to their trial dossier, reply to member state requests for information and provide trial notifications, such as when a trial starts, recruitment begins, trials end, serious breaches happen and findings summaries are ready (CenterWatch Weekly, Aug. 8, 2022).