Abstract
Author(s): Raju Sama*, Swarna Latha K, Sathish M, Gowthami Krishna M and Santhosh P
Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical environment. Electronic Common Technical Document (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 Harmonisation 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 are to be faced regulatory departments. This paper describes eCTD History, Benefits of Implementing, Challenges, Modules, Risks involved in eCTD publishing and Quality Control.