The European Medicines Regulatory Network has launched a new telematics project called the Digital Application Dataset Integration project (DADI) to modernise and improve use of the EU electronic Application Forms (eAFs). DADI has been established as the successor to the Common European Single Submission Portal (CESSP) phase 1 project.
The Digital Application Dataset Integration (DADI) project will replace the current PDF-file based electronic application forms (eAFs), making the future form-filling and submission handling process more efficient. The new web-based system will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard, [...]
The eCTD EU Module 1 specification has been updated. The updated EU M1 spec v3.0.4 and the related release notes are available here. There are no changes to the DTD and hence this version enters into force as of date of publication and can be used immediately. It is recommended to use the new version [...]
The EU eCTD Module 1 Specification has been updated to reflect clarifications and the updated version 3.0.4 is available for immediate use. Release notes with practical information on changes are provided below. There are no changes to the DTD in this version (version 3.0.1 is still valid), and the validation criterion was not changed as [...]
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced changes to the delivery file (addition of 'nitrosamine related' radio button for initial variation submissions (human domain only) and renaming the 'Customer Reference' field to 'purchase order number' for all relevant submission types and submission units [...]
Lead Member State PSUR Follow-Up assessment report (February 2025) [Track version]
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is now available. This update has introduced changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number).
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is planned for release in the evening of 8th March 2021. This update will introduce changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number). Users [...]
An updated version of the eSubmission Gateway XML delivery file user interface is planned for release in the evening of 11th March 2021. This update will introduce changes to the delivery file (addition of ‘nitrosamine relate' radio button for initial variation submissions and renaming the 'Customer Reference' field to PO number for all relevant submission [...]
Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products Appendix 1: Acceptable intakes established for N-nitrosamines Appendix 2 : Carcinogenic Potency Categorisation Approach for N-nitrosamines Appendix 3 : Enhanced Ames Test Conditions for N-nitrosamines