During our last webinar on eCTD, multiple participants asked for insight regarding the status of the pilot PSUR repository pilot at EMA. I attended a recent EMA webinar on January 13th and just wanted to give you quick update as to where we stand on this.
In short, the pilot phase of the new repository represents very little change for MAHs who have already been using the eSubmission Gateway/Web Client for PSUR submissions; both will continue to be used. What has changed is the use of a simplified zip package filename and a new XML delivery file. EMA has stated that filenames will not be validated for PSUR Repository Submissions, but that the package should have a meaningful name for archiving purposes.
While we had hoped that the new PSUR Repository would allow for more bundling of submissions, what EMA has delivered with the pilot repository has not accomplished this. They are still working.
The PSUR Repository was successfully deployed by EMA on January 26, 2105 and phase 1 of this project (voluntary participation) has begun.
If your company elected to participate in the pilot, you should have already informed EMA. If you changed your mind, you need to let them know as it gives them the capability to inform affected Member States.
Don’t panic about the change. It won’t be as painful as you might think.