March 2023: CTIS Newsflash

On March 10, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page.

The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, and CTAs with a decision per RMS for the week of February 28 to March 06, 2023, as compared to the previous week.

Below are the key updates from the newsflash:

  • Multi-factor (MFA) authentication strategy: From June 01, 2023, users for both Sponsor and Member State workspaces will need to log in to CTIS using an MFA along with their respective username and password. Users may choose their preferred second-factor method and amend their MFA options (a token in the Microsoft app, text to a mobile phone, or call on an office phone) at any time. Users can sign into the EMA ServiceNow portal to configure their MFA for EMA systems, which, once deployed and enabled, will also work for CTIS.
  • Submission of partial initial clinical trial application:
  1. As per the requirements of Article 11 of the Clinical Trial Regulation (CTR), sponsors can submit partial initial clinical trial applications by submitting an application with Part I to all Member States Concerned (MSC) and part II to none or some MSC.
  2. From the time Part I is submitted until a decision is issued by the Member State, the initial application will remain under evaluation for 2 years, after which the application will lapse.
  3. The submission of further applications, such as substantial modifications and/or addition of an MSC, can only occur after all MSC have received both Part I and Part II of the dossier.
  4. Any future changes to the partial initial application functionality in CTIS will be communicated to users in advance.