Changes to product information following the outcome of imposed non-interventional post-authorisation safety studies (PASS) can be found on: for centrally authorised products (CAPs) - the outcomes of imposed non-interventional PASS final study results assessments are published as part of each medicine's European public assessment report (EPAR) and the Decision will be published per product for [...]
An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update has introduced an additional submission unit for PAM submissions and a mandatory selection of yes/no to indicate if a change of MAH is included in a response submission for MAA human and vet. Additionally some minor [...]
A new version of the eSubmission Gateway XML delivery file user interface is now available. Following this release the use of the Formatted Letter template will become obsolete as of 1st January 2020. This will concern all EMA Human and Veterinary submissions (including PSUSA procedures) and after this it will be optional for applicants to [...]
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 [...]