On March 26, 2026, EMA published an updated CTIS FAQ for sponsors.
Many questions sponsors had about the publication of Anonymized CSRs on CTIS have now been answered with very practical solutions. Specifically, sponsors can choose to upload a note on company letter head indicating that the final anonymized CSR will be available on the Clinical Data Publication website.
See questions 5.9 and 5.10 for more details and recommended wording.
The updated Sponsor Frequently Asked Questions document can be accessed here.







