Choosing the right format for your regulatory submissions

To create a uniform format for pharmaceutical regulatory submissions, the International Council for Harmonization created CTD. As technology advanced, the demand for electronic submissions increased, giving rise to eCTD and NeeS. NeeS, which offers an electronic version of CTD but has fewer technical capabilities than eCTD, was created as a transitional step. Because of its XML base, eCTD has long been the norm for regulatory submissions providing advanced features improving regulatory efficiency.

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