Dossplorer now supports Swiss Module 1 Specification v1.4 eCTD submissions, without the release of a new software version!
Dossplorer now supports Swiss Module 1 v1.4 submissions. The updated schema for Swiss eCTDs is uploaded to Dossplorer's hybrid cloud-platform. Customers are able to import and view Swiss eCTDs using the latest schema.
For most applications an update of the regional module 1 schema will automatically result in an increment of the software version. This has a big (financial) impact on IT and validation effort required to support the update.
Dossplorer is capable of adding new or changed schema files to the existing platform, without the need to update the application version. This ensures timely support of the latest eCTD version with minimum impact.
As of 01 January 2019, the new Swiss Module 1 Specification for eCTD v1.4 will be implemented. There will be a transition period for half a year, from 01 January 2019 to 30 June 2019, where both versions of the Swiss Module 1 Specification for eCTD (v1.3 and v1.4) will be valid and accepted by Swissmedic. As of 01 July 2019, only eCTD submission in accordance with the Swiss Module 1 Specification v1.4 will be valid.