PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 15:00 and 17:00 on Tuesday, 27 June 2017. However, Axway gateway will be available for all communities and any files submitted during that time will be put in a queue for processing when the deployments will be completed.
A presentation on the outcome of the first ‘proof of concept' User Acceptance Testing (UAT) on the Common European Single Submission Portal (CESSP) is now available here.
At the ICH meeting in Montreal, Canada, on 27 May to 1 June 2017, the ICH Assembly and ICH Management Committee made some revisions to the Articles of Association, Rules of Procedure and Standard Operating Procedures for Working Groups.
The ICH M7(R1) Addendum reached Step 4 of the ICH process in May 2017 and now enters into the implementation period (Step 5).
The International Council for Harmonisation (ICH) met in Montreal, Canada on 27 May to 1 June 2017.
The ICH MedDRA Management Board met in Montreal, Canada on May 27-28, 2017 and announces its coordination with the WHO Collaborating Centre for International Drug Monitoring...
An updated version of the eSubmission Gateway Web UI is now available. This version delivers defect fixes and addresses a data protection concern as the application contact person name and contact person contact details are no longer visible in the user interface and the XML delivery file. Details on the defect new fields are described [...]
Template CMS comments in MRP (January 2024)
CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity [Track version](June 2023)
The eSubmission Validation checklist - version 2.5 (entering into force June 2017) has been updated and can be found here.