Abstract

PROSPECTIVE STUDY OF GOOD PRACTICE FOR MANAGEMENT OF COMMENTS / DEFICIENCES IN CTD / e-CTD

J. Praveen Kumar*, V. R. Pranathi and Dr. M. Kishore Babu

ABSTRACT

eCTD or electronic common technical document is an interface designed for the pharmaceutical industry to transfer regulatory information. The International Conference on Harmonization (ICH M2) developed this module-based regulatory application format. In 2008 the FDA (Food and Drug Administration) made eCTD format compulsory for all electronic submissions. The role of eCTD is to help pharmaceutical companies enhance the submission procedure by bridging the gap between the time and market and minimizing expenses. However, a recent analysis made by the Open Text™ Corp (a leading company in enterprise content management), it’s found out that most of the pharmaceutical companies are struggling hard to meet the deadline created by FDA to comply with the standard using eCTD format.

Keywords: eCTD, FDA, ICH.