From 21 July, users of the Common European Submission Portal (CESP) experienced around two weeks of intermittent Web Integrated Upload issues, including access problems, rejected uploads, delayed processing and download failures. For a platform supporting regulatory submissions across Europe, this was an exceptional disruption.
Impact
For Regulatory Affairs and Operations teams, such outages create uncertainty: deadlines remain, receipt by authorities may be delayed, workload increases through monitoring and follow-up, and regulatory risk can rise when timely delivery cannot be confirmed.
What should companies do?
The key lesson is clear: companies need a documented submission contingency plan. They should know authority-specific alternatives in advance, understand when routes such as Eudralink may be accepted, and keep agency requirements readily available.
All upload attempts, timestamps, error messages, support tickets and authority communications should be documented.
Companies need contingency plans, but platform resilience is equally important. From the side of CESP, clear contingency guidance and post-incident reviews would also help both NCAs and industry understand acceptable alternatives and improve overall submission resilience.
Digitalisation has made regulatory submissions more efficient, but also more dependent on reliable platforms. The CESP outage shows that Regulatory Operations is not only about preparing a correct dossier, but also about ensuring it can be delivered, received and evidenced on time.
Need support strengthening your submission contingency approach? Visit www.starodub.nl.
