The ICH Reflection Paper which the ICH Assembly decided to progress at its recent meeting in Vancouver, Canada on 13 June 2023, is now available for public consultation until 30 September 2023 on the ICH website
Support to eSubmissions during EMA holidays; Please note that all EMA eSubmission systems are running as per normal during the EMA holiday. Submissions received via the eSubmission Gateway during the EMA closure are automatically uploaded to the Common Repository and the PSUR Repository as relevant. In case of technical issues, the EMA IT service desk [...]
The release schedule for the update of the electronic Application Forms (eAFs) is now available and can be found here. The next release, version 1.21 will deliver defect fixes and usability improvements and is planned for user acceptance testing in January 2017 and for deployment in February 2017.
We are pleased to inform you that an updated version of the PSUR Repository NCA UI is going live on the 3rd of July 2023.
VNeeS guideline v 2.5 and validation checklist v2.5 have been published and will enter into force in June 2017. With this new version 2.5, rules for technical validation remain unchanged, therefore the current VNeeS Checker v.2.4b (validation tool) will remain valid from June 2017.
Due to planned maintenance and verification of the upcoming functionalities (including basic authentication), the Common Repository (API and Web UI) will not be available on Tuesday 27 June 2023, between 18:00 and 21:00. For any further information, please contact EMA Service Desk.
Today the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are announcing a new collaboration to enhance registry and sharing of regulatory information on medical products worldwide.
Wilfactin (Human Von Willebrand Factor) End of Procedure: 13/01/2023 Date of publication: 30/06/2023
Please note that the following computer systems will be unavailable on Sunday, 4th December 2016 between 9.00hrs and 19.00hrs (UK Time) due to essential maintenance: PSUR and eSubmission Web User Interface - affecting parts of DREAM* Axway Gateway - affecting EudraVigilance and eSubmissions (* Due to essential folder re-structuring, colleagues working in the cabinet 01 [...]
The VNeeS format is becoming mandatory for ALL submissions in European procedures (CP, DCP and MRP) as of 1 January 2017, as detailed in the Annex to the eSubmission roadmap.