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#electronic_common_technical_document

Electronic common technical document

The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group.

Sat 20th

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Electronic common technical document Common Technical Document Specification (technical standard) Certificate of pharmaceutical product Marketing authorisation Document management system Pharmaceuticals and Medical Devices Agency Clinical data management system Identity document ClinicalTrials.gov
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