Electronic Common Technical Document (eCTD): A Review of History, Benefits of Implementing, Challenges, Modules and Risks Involved in eCTD Publishing

Abstract

Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical environment. eCTD is an interface for the pharmaceutical industry to agency transfer of regulatory information. Since June 2003, applicants have had the option of submitting an eCTD in parallel with the paper submission (Common Technical Document), following sign-off by the International Conference on Harmonization Steering Committee of the eCTD Specification document at Step 4. It is designed to make regulatory submissions easier and more efficient for drug makers and for regulators. When it comes to eCTD submission, there continues to be differences among different countries and even ICH regions. The standardization that electronic submissions will bring will allow for much greater consistency not only for the regulators but also for organizations. It is important that eCTD ready documents are prepared by authoring them in eCTD compliant templates. If this is not undertaken, a large amount of the “publishing time” is spent in document reformatting. As the move from paper-based to eCTD submissions continues around the world, a multitude of challenges is to be faced regulatory departments. This paper describes eCTD History, Benefits of Implementing, Challenges, Modules, Risks involved in eCTD publishing and Quality Control.

Keywords: Electronic Common Technical Document, Benefits, Challenges, Modules

Cite this Article

Praveen Agarwal, Anil Dewangan, Pavani Duggi. Electronic Common Technical Document (eCTD): A Review of History, Benefits of Implementing, Challenges, Modules and Risks Involved in eCTD Publishing. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(3): 1–16p.