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eSubmissions and eCTD
An eSubmission designates an electronic application that manufacturers of medicinal products submit to the competent authorities.
The ICH eCTD format provides the specifications for a standardised shape for eSubmissions in terms of structure, metadata and file formats. The content of the specifications is based on the definitions used for Common Technical Documents (CTD) and consists of 5 modules. Module 1 includes country- and region-specific information defined by the competent authorities. Modules 2-5 are in accordance with ICH specifications.
(For further information on eSubmissions and the ICH eCTD specifications, see here.)
Swissmedic recommends eCTD submissions
Swissmedic is making use of best practice experiences thanks to the collaboration with other agencies and the industry. Regarding the eCTD format, Swissmedic strives to ensure that eCTD requirements conform to EU specifications (except for Module 1).
Overview of the information regarding Swissmedic eSubmissions
Information regarding Swissmedic eSubmissions includes:
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