The future of Regulatory Submissions: Transition to eCTD 4.0

  • Komal Nagar Department of Regulatory Affairs, School of Pharmaceutical Sciences, MVN University, Palwal (NCR) – 121105, Haryana, India
  • Mamta Choudhary Department of Regulatory Affairs, School of Pharmaceutical Sciences, MVN University, Palwal (NCR) – 121105, Haryana, India
  • Bharti Yadav Department of Regulatory Affairs, School of Pharmaceutical Sciences, MVN University, Palwal (NCR) – 121105, Haryana, India
  • Shivali Rahi Department of Regulatory Affairs, School of Pharmaceutical Sciences, MVN University, Palwal (NCR) – 121105, Haryana, India
  • Ashutosh Upadhayay Department. of Pharmacology, School of Pharmaceutical Sciences, MVN University, Palwal (NCR) – 121105, Haryana, India
DOI https://doi.org/10.22270/ijdra.v13i3.788

Abstract

As a global standard for regulatory submissions, the electronic Common Technical Document (eCTD) has improved efficiency among health authorities and streamlined procedures for pharmaceutical and biological products. The introduction of eCTD version 4.0 represents a significant digital leap with enhanced lifecycle management, interoperability, and message-based architecture. This transition supports more effective data handling and fosters cross-border regulatory cooperation. eCTD 4.0 offers advantages such as reduced redundancy, real-time communication, and increased submission flexibility by moving away from document-centric models to a modular, data-centric framework. Regulatory agencies including the FDA, EMA, PMDA, and Health Canada are at various implementation stages, signaling global commitment to submission modernization. This review examines the evolution, benefits, challenges, and strategic opportunities associated with the implementation of eCTD 4.0 in global regulatory systems.


Conclusion: The transition to eCTD 4.0 marks a major advancement in regulatory submissions, offering a more flexible, interoperable, and data-driven framework. By addressing the limitations of earlier versions, it enables improved efficiency, communication, and global harmonization.

Keywords: eCTD 4.0, regulatory submissions, lifecycle management, digital transformation, global harmonization, regulatory agencies, FDA, ICH

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1.
Nagar K, Choudhary M, Yadav B, Rahi S, Upadhayay A. The future of Regulatory Submissions: Transition to eCTD 4.0. Int J Drug Reg Affairs [Internet]. 2025Sep.16 [cited 2025Nov.11];13(3):77-4. Available from: https://www.ijdra.com/index.php/journal/article/view/788
Issue
Vol 13 No 3 (2025): VOLUME 13, ISSUE 3, 2025
Section
Review
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