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"
For More Information Please Click: Exalon: New Status Reports for ESG
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