Abstract

The adoption of the electronic Common Technical Document (eCTD) 4.0 provides considerable competitive advantages for Indian pharmaceutical companies. It offers universal document reuse (UUIDs) and two-way regulatory communication which, in turn, facilitate submissions, improve data integrity and accelerate time to major international markets. However, eCTD 4.0 adoption is a significant transition to a data-centric, message-based model (HL7 RPS standard) from version 3.2.2, which is document-centric in design.

This article examines the major characteristics of eCTD 4.0 and its implementation requirements. Through a comprehensive literature review, it compares regulatory submissions in India, the US and Europe, and examines India’s regulatory modernisation initiatives and its eCTD 4.0 adoption roadmap. It also considers the challenges involved in its adoption and makes evidence-based recommendations to stakeholders planning a similar transition.