#mhra guidelines

e-Dossier Submission: Regulatory and Procedural Guidance

When businesses move to the online standard Electronic Common Technical Document (eCTD) format, they are gradually uncovering some burdens. eCTDs which fail to meet technical validation requirements can result in rejection by health authorities. Health authorities are raising the bar for reliable, compliant eCTDs because of pressure to meet deadlines for the process.

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eCTD: Electronic Regulatory Submission

Rather than going through hours now one can pull up a 3-year-old application of investigational new drug (IND) and look at it with a couple of clicks in the current view as well as a historical view. The secret to this noteworthy change is the Electronic Common Technical Document (eCTD), which represents a major step forward in the march toward electronic regulatory submissions worldwide. The eCTD defines how electronic submissions are to be made, reviewed and archived as specified by the International Conference on Harmonization (ICH) back in 2003.