A COMPARATIVE STUDY OF eCTD IMPLEMENTATION, LIFECYCLE MANAGEMENT AND TECHNICAL REQUIREMENTS ACROSS MAJOR REGULATORY AUTHORITIES

The electronic Common Technical Document (eCTD) is the principal standard for electronic exchange of pharmaceutical regulatory information between applicants and health authorities. Although the scientific organization of Modules 2–5 is broadly harmonized through the International Council for Harmonisation (ICH), implementation remains regionally differentiated through Module 1, validation criteria, controlled vocabularies, submission gateways, lifecycle conventions and transition schedules. This review compares eCTD implementation, lifecycle management and technical requirements across the US Food and Drug Administration (FDA), European Union/European Medicines Agency (EU/EMA), Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, Health Canada and the Therapeutic Goods Administration (TGA) of Australia. Particular emphasis is placed on the transition from eCTD v3.2.2 to eCTD v4.0, including metadata-driven regulatory information exchange, Universally Unique Identifiers (UUIDs), controlled vocabulary, document reuse, forward compatibility and two-way communication. The latest ICH eCTD v4.0 Implementation Guide version 1.7 was endorsed in June 2026. Japan has entered mandatory v4.0 implementation, while FDA and EU adoption are progressing through phased transition. The review concludes that efficient multinational submissions require a harmonized scientific core combined with strong regional publishing governance, current validation rules and integrated regulatory information management.

Keywords: eCTD; eCTD v4.0; CTD; regulatory submissions; lifecycle management; FDA; EMA; PMDA; Health Canada; TGA; regulatory information management.