A Review on Next Generation eCTD – eCTD v4.0

Abstract

eCTD 4.0 is the first major upgrade of eCTD in over a decade, designed to meet the objective of using a single electronic message standard for exchange of regulatory information through internationally approved standards. It is based on the Health Level Seven (HL7) Standard called Regulatory Product Submissions (RPS). HL7 is an ISO-certified standards body that builds health standards, specifically for North America but has been adopted worldwide. With RPS, the regulatory information is transferred in the form of an xml message that is represented by the colour coded R-MIM (Refined Message Information Model) diagram which efficiently describes each content of the regulatory data to be processed and exchanged between sponsors and regulatory authorities. The International Council on Harmonisation (ICH) has adopted the RPS standard as basis for eCTD version 4.0, and implementation guides for this format have been issued by ICH, US FDA, Health Canada, Japan PMDA, and EU EMA. ICH has built requirements into RPS that significantly enhances the regulatory submission and review process for sponsors and regulatory officials in the eCTD v4.0 version. This review provides a brief outlook on the new eCTD v4.0 standard.