An updated version of the eSubmission Gateway Web UI is now available. This version delivers new functionality to provide information currently provided in the Formatted Table Template. The aim of this phased implementation is to stop using the template once all relevant fields are available in the XML delivery file. This particular release does not [...]
The ICH Management Committee identified the Expert & Implementation Working Groups to meet at the upcoming ICH meeting to take place in Montreal.
The Annex 2 of the eSubmission Roadmap on the implementation of mandatory use of eCTD format for regulatory submissions has been updated to reflect the updated eSubmission Roadmap v2.0 and is now available.
Four links to presentations and tutorials have been removed from this page as they focus on human eCTD submissions, not veterinary. They can be found on the eSubmission Gateway and WebClient. Additionally, eSubmission Validation checklist - version 2.5 - clean (entering into force June 2017) is now available.
Urgent Safety Restriction Member States' Standard Operating Procedure (October 2024) [Track version]
An updated version of the eSubmission Roadmap has been published. The Roadmap has been updated to reflect achieved milestones and to include new and amended timelines for implementation of various telematics systems/standards. The Annexes related to the eSubmission Roadmap will be updated in line of the changes detailed in the roadmap. The updated annexes will [...]
Pediacel (diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) End of Procedure: 24/11/2016 Date of Publication: 23/02/2017
The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), regarding the selection and justification of starting materials, reached Step 2b of the ICH Process in November 2016 and now enters the consultation period.
The ICH E11(R1) draft Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process and is currently under public consultation.
ICH E6(R1) on Good Clinical Practice (GCP) has been amended to encourage implementation of improved and more efficient approaches to clinical trials design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.