Website outages and system releases

The European Medicines Agency (EMA) makes upgrades to this website and the Clinical Trials Information System (CTIS) from time to time, to improve user experience. 

During these times, CTIS and this website may be temporarily unavailable or not work optimally. 

You can see when we are planning the next outage below. Registered users can also see notice of any planned interruptions in EMA Service Desk. 

Below you can find the full release notes and a list of any outstanding issues and proposed workarounds for these issues. 

Some functionalities within CTIS rely on other systems which are also maintained by EMA. Upgrades and related work on any of these systems can affect CTIS users’ ability to perform some actions. You can see when we are planning the next maintenance on these systems below.

Planned interruptions CTIS

EMA advises you to avoid the following periods for using CTIS or the website search:

  • Friday 24 June: 18:00-20:00 Amsterdam time
  • Each Tuesday and Thursday: 18:00 – 21:00 Amsterdam time
  • Each first Saturday of the month, from 10:00 – 14:00 Amsterdam time

This information is relevant for EMA systems’ users only.

EMA Account Management

  • Wednesday 18 March: 20:00 – 20:30 Amsterdam time.

During this time slot, CTIS users cannot perform the below actions in EMA Account Management:

  • Self register for an EMA Account

  • Request, grant or remove access to CTIS

During the downtime registered users will be able to log into CTIS.

Read more about EMA Account Management

Organisation Management System (OMS)

During this time slot, CTIS users cannot perform the below actions in CTIS:

  • Each Tuesday: 18:00 – 21:00 Amsterdam time.

During this time slot, CTIS users cannot perform the below actions in CTIS

  • User administration:
    • Updating your employer data
    • Assigning or requesting a role
    • Assigning a role to a Member State National Organisation Administrator (NOA)
  • Clinical trial application:​
    • Creating a new clinical trial initial application
    • Adding a sponsor to a clinical trial initial application
    • Adding a contact point for Scientific Advice, or as a Legal Representative or Third Party
    • Adding a trial site to part II​ of the application
  • Other:
    • Adding a site to an inspection
    • Creating a new Annual Safety Report

You might see error messages appear in CTIS when you are trying to execute these actions indicating that the OMS is not available.

Read more about the OMS

About release notes

These documents outline the latest updates to the CTIS system, including the secure Sponsor and Authority workspaces, and to the Clinical Trials website. Updates may include improvements to existing features and functionality, the addition of new features and functionality and technical improvements.

Support and training

User support service
If you cannot find an answer to your question in the guidance and Q&As, please contact the User support service.
Guidance and Q&As
Find questions and answers on how to use CTIS.
Training on using CTIS
If you cannot find an answer to your question, please consult our training and supporting materials on how to use CTIS.