The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the requirements for imminent changes to the Certification of Suitability (CEP) application process.
 
On 1 November, EDQM will introduce automation to improve its process for receiving CEP submissions. As part of the change, EDQM will require filings with electronic common technical document (eCTD) sections to be validated against the currently applicable EU region criteria. EDQM wants applicants to perform the task using an appropriate eCTD validation tool.
 
“It is important that these updated requirements are taken into account when preparing and submitting applications,” EDQM said. “Failure to do so will delay validation or may lead to the application being blocked on receipt.”
 
Applicants must correct any fail errors identified during eCTD validation before sending their submissions to EDQM. The directorate has provided advice on the validation report location, naming, and file format requirements. EDQM also updated its guide to using the Common European Submission Portal to reflect changes to CEP filings. [EDQM]