ABSTRACT

This current review article underscores necessity of electronic Common Technical Document (eCTD) software as advanced tool for variety regulatory submissions. Electronic Common Technical Document can be considered as one of the most useful tool especially to create dossiers for several specified as well as Common Technical Document (CTD) format, which is expected to be used and reduce the amount of time and resources required by the sector to collect global reports and applications for registration. An Electronic Common Technical Document is composed of individual PDF documents arranged in accordance with the structure of the Common Technical Document in an organized manner. The present review article provides a guide for creating an Electronic Common Technical Document using the latest software, accompanied by detailed step-by-step instructions for utilizing the specified software. Furthermore, this current review article extends to include a concise comparison of the filling procedures for the Electronic Common Technical Document in accordance with both United States Food and Drug Administration and European guidelines. Keywords: Common technical Documents, Dossier Submission, electronic Common Technical Documents, European guidelines, Portable Document Format, United States Food and Drug Administration
Publication date: 01/01/2025

https://ijbpas.com/pdf/2025/January/MS_IJBPAS_2025_8656.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.1.8656