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Overview of the Common Technical Document by Neha Hazra is a document available to read on EtoBox.

What is Overview of the Common Technical Document about?

The Common Technical Document (CTD) is an internationally agreed format for the submission of drug registration applications, established by the International Conference on Harmonisation (ICH) to streamline the process across Europe, Japan, and the U.S. It consists of five modules that cover general information, summaries, quality, non-clinical study reports, and clinical study reports, facilitating easier and more efficient regulatory submissions. The electronic version, known as eCTD, enhances submission

Author

Neha Hazra

Language

EN