PSUR and eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00-09:00hrs (CEST) on Wednesday, 9 October 2019. However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete. If you have any questions, [...]
Added in September 2023 11 September NEW - 12-14 September 2023 CMDh agenda
Version 1.23.1.3 of the 4 electronic Application Forms (eAF) will be available 10 October 2019. The release v1.23.1.3 is a bug fix release to correct a number of issues affecting the forms. More details on the fixes will be available in the release notes which will be published together with the updated forms. This hotfix [...]
Please be informed that the VHG reached a decision regarding mandatory use of the PDF/A format in VNeeS, starting after the transition period when the CESP dataset module becomes mandatory for all submission types. The current planning in the new version of the eSubmission Roadmap that was recently adopted by HMA currently says that the [...]
As per the structure of the eCTD, the product information should be provided in pdf format within Module 1.1.3. However it is occasionally necessary to provide, in addition to the PDF requirement, product information or the Module 2 documents in Word format. These files should be provided outside of the eCTD structure, in a separate [...]
The ICH M8 EWG would like to assess the readiness of eCTD v4.0 Vendors and their development and/or readiness to deliver a production ready eCTD v4.0 solution. We request that the eCTD v4.0 Vendor Readiness Survey be completed by September 15, 2019.
A webinar providing an update of the CESSP phase 1 project (converting the current eAFs into web based forms) will be held on 7 May 2019 from 10:00 to 11:30 CET. This webinar is aimed for applicants (from pharmaceutical industry). A separate session aimed for regulators will be be organised in near future.Please note that [...]
The release notes for MAA Human and Veterinary electronic Application Forms (eAF) and the Renewal eAF have been updated to reflect new known issues
A minor update has been made to the Q and A on how to handle ongloing procedures in relation to mandatory eCTD format.
Due to planned maintenance, the PSUR Repository (both NCA and Industry portals) will not be available on Saturday,2 September 2023, between 9:00 and 17:00. For any further information, please contact EMA Service Desk.