eSubmission:
- eSubmission Gateway XML delivery file update for Raw Data submissions:
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file (addition of new submission type for 'Raw data submission' (human domain only). Further information on the Raw data pilot submissions can be found here: https://lnkd.in/egmVX29d
Please note that this new submission type should only be used when it has been previously agreed that the product is taking part in the pilot. The details on the changes are provided in the following:
Release notes: https://lnkd.in/e7pqegdD
Updated user guide: https://lnkd.in/e7pqegdD
Previously created delivery files should continue to work, however, it is always recommended to clear the cookies and the cache to ensure that the system works correctly.
- CTD EU Module 1 Specification now open for review and all stakeholders are invited to submit change requests on the specification - deadline extended until 1st November 2022
The Human Harmonisation Group has decided to open the eCTD EU Module 1 Specification for review and all stakeholders are invited to review the list of submitted change requests and, to submit new change requests on the specification.
Specification: https://lnkd.in/dQy87uGP
Please find a list of submitted change requests and the template to submit any new change requests to the current version of the eCTD EU M1 specification.
Submitted Change Requests: https://lnkd.in/dFMyXAiG
Template: https://lnkd.in/edBa-3HE
The comments should be submitted via email to EUM1Spec@ema.europa.eu by end of the day 1st of November 2022.
