EMA IT systems unavailable from 18:00 Friday 28 October to 6:00 Tuesday 1 November
All European Medicines Agency (EMA) IT systems will be temporarily unavailable from 18:00 on Friday 28 October to 6:00 on Tuesday 1 November (UK time), due to an essential exercise to test the Agency’s IT recovery processes in case of a major event.
During this period, it will not be possible to access the EMA public website, www.ema.europa.eu, or any other EMA-hosted website or online application, including the EU Clinical Trials Register. Normal service will resume on 1 November.
Emails sent to EMA email addresses during this period will be queued and delivered to recipients on 1 November.
We would like to thank you in advance for your patience and cooperation during this essential IT maintenance work.
The system has been made available on 13 January 2016. The summary results will be gradually made available for public access from that date, once the information has been reviewed and verified. Full access for sponsors has also been restored from that date.
In the context of clinical trial sponsors’ or PIP addressees’ inability to meet regulatory reporting timeframes while the system was offline: The new deadline for submission for all summary results affected by the period that the system was offline will be 13 July 2016, allowing a period of six months from the date of re-opening of the system. Affected results are those whose submission deadline fell due during the period that the system was offline, as well as those whose submission deadline falls within a period of two months from the re-opening date.
In addition, for trials categorised as to be posted ≤ 24 months after finalisation of the programming (see document “Trial results: modalities and timing of posting”), the deadline for submission of summary results will be 21 December 2016, being five months from the current deadline in July 2016.
The issues causing errors in data recording have been fixed. These are described in the release notes (see “timestamp” and “category” issues). The results presented are correct. However, the issue that causes the order of display of reporting groups and results to differ through the results set has not been addressed. The reporting groups and results themselves are correct; it is only the display order that is affected.
EU Clinical Trials Register version 2.1