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The European Medicines Agency has released new status reports regarding the European eSubmission Gateway and the electronic Application Form (eAF) projects. Both status reports have the report date "June 2011" and are available for download from the "eSubmission" website of the Agency.
Short summary eSubmission Gateway Project:
The eSubmission Gateway will use Axway technology to allow registered business partners to send eCTD submissions electronically to the EMA via the gateway. Progress of the project has been delayed for several months due to the resignation of the project manager and subsequently the entire development and test team (see previous status report from March 2011). - According to the new status report the business requirements and software architecture documentation for release 1 of the gateway are final and development test phase have been completed. System testing is currently ongoing and will be completed in June followed by the user acceptance testing.
- Modified work instructions for the handling of incoming eCTD submissions and details about the registration process will be published in July 2011.
- The pilot phase is planned to start also in July 2011 whereas the start of the production phase of Release 1 of the eSubmission Gateway is planned for October 2011. The Agency expects that "that both methods to submit eCTDs (via CDs/DVDs and via eSubmission Gateway) will be supported for some time"
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Short summary eAF status report:
The eAF project has the purpose to provide a European standard for electronic exchange of structured administrative information contained in application forms for marketing authorisation applications, renewals and variations of medicinal products (for human and veterinary use) between Industry and European Regulatory Authorities and to facilitate the automated processing of this information by all concerned parties by utilization of XML technology.
Specifications have been published as part of the EudraLex "Volume 2B - Presentation and Content of the Dossier" (see here). The corresponding Data Exchange Standard, version 3.0 has been published earlier. Note: The basis for the development of the MAA Human form is the "Module 1: Administrative information Application form" from May 2008. The recent changes to the MAA Human (Module1: Administrative information Application form, June 2010) form are currently not in the scope of the eAF Release 1.0.
- The development for eAF Release 1.0 as well as development testing is complete. System testing is partially complete and User Acceptance Testing has started.
- Starting of the pilot phase is planned for August 2011
- Starting of the production phase is planned for October 2011
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[Source: EMA eSubmission website]
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