Abstract

CTD – A CRITICAL DOCUMENT FOR DOSSIER SUBMISSIONS: AN OVERVIEW

K. P. R. Chowdary*, K. Ravi Shankar and G. Saranya

ABSTRACT

New drug development process is highly regulated. Every drug before getting market approval must undergo rigorous scrutiny and clinical trials to ensure its safety, efficacy and quality. A dossier containing detailed information about the drug and results of the studies carried out in its development process has to be submitted to the regulating bodies for getting marketing authorization. CTD (Common Technical Document) is critical for dossier submissions. Literature on CTD, its structure and modules and details of information to be included in CTD and eCTD submissions are reviewed in this article.

Keywords: New Drug Approval Process, Dossier, CTD, eCTD.