A presentation on the outcome of the first ‘proof of concept’ UAT on CESSP is now available here.
Essential maintenance to EMA computer applications affecting PSUR Repository on Saturday, 24 June
PSUR/eSubmissions Web User Interface (to create the delivery file) will be intermittently unavailable between 09:00 and 19:00 on Saturday, 24 June due to essential maintenance. EMA’s gateway will remain available for all communities throughout and any files submitted during that time will be put in a queue for processing once the deployments have been completed.
If you have any questions, please contact the EMA Service Desk.
New versions of the 4 electronic Application Forms (eAF v. 1.21) and the related release notes are now available here. This version of the forms provides usability improvements and defect fixes and aims to improve the user experience for all users. This new version, 1.21 of the forms can be used as of today (20th June 2017) and will fully replace the version 126.96.36.199 after transitional period, on1 September 2017. Version 188.8.131.52 of the forms will be withdrawn from the eAF website on 20th June 2017 however it may be used until 31st August 2017. The version of the form should not be changed during an ongoing procedure.
Version 1.21 of the eAFs will be available on 20 June 2017. The release v1.21 provides usability improvements and technical defect fixes. Following a successful User Acceptance Testing (UAT) the release schedule has now available to provide more information regarding the mandatory use of version 1.21.
An updated version of the eSubmission Gateway XML delivery file user interface and the PSUR Repository is planned for Tuesday 27th June 2017. The eSubmission Gateway UI update will introduce improvements to the user interface and new fields. This change is a further step towards integration of the XML delivery file and the Formatted Table Template; however this release does not affect the use of the Formatted Table Template.
Users should note that in some cases delivery files created prior to the new release on 27th June 2017 may not work following the deployment of the new versions. It is recommended to clear the cookies and refresh your browser before creating delivery files using the updated user interface to avoid any issues.
An interactive training session introducing the changes on the eSubmission Gateway delivery file will be held on Monday 26th June at 11am UK time. Attendance is on first come first serve basis.
To register to join the training please contact: eSubProgOfficer@ema.europa.eu by Friday 23rd June 2017.
Essential IT maintenance to EudraVigilance applications the Weekend of June 17th 2017
Due to essential maintenance between Friday, 16th June 2017 17:00hrs and Sunday 18th June 2017 23:30hrs (UK time), EudraVigilance Human (for ICSR and Product) and EudraVigilance Veterinary (including EV Web and Gateway) will be unavailable. For any questions, please contact the EMA Service Desk.
An updated version of the eCTD v4.0 EU M1 Implementation Guide is now available for public consultation. The eSubmission Change Management Board invites all pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities to take part in this consultation and provide comments by 30th September 2017. Please provide your comments using the comment template; and any questions regarding further development and clarifications of the released draft documents to: eCTD4consultation@ema.europa.eu. The Implementation Guide and relevant documents can be found here.
The Annex VI of the eSubmission Roadmap on the implementation of mandatory use of VNeeS format for Veterinary regulatory submissions has been updated to reflect the updated eSubmission Roadmap v2.0 and is now available here.
Version 1.21 of the eAFs will become available on 20 June 2017. The release v1.21 will provide usability improvements and technical defect fixes.
We are organising a User Acceptance Testing (UAT) to support the release of this next version of the forms:
- The testing by Industry and NCAs will take place
- Industry: from Mon 22/05/17 to Fri 26/05/17
- NCAs*: from Mon 29/05/17 to Fri 02/06/17 (*Based on the eAFs received from Industry)
If you wish to participate, please email eSubprogofficer@ema.europa.eu. A feedback form for consolidated comments will be provided to you following your registration.
Previous news is available here