eCTD, a standardized submissions format, was established based on the Regulatory Product Submissions (RPS) standard (HL7 standard) with advice from the ICH. The current eCTD version 3.2.2 will soon be replaced by version 4.0.  With various modifications designed to simplify the process for sponsors and Regulatory authorities, eCTD V4.0 has officially been issued. The primary goal is to implement changes that speed up the Regulatory submission process, enhance communication between agencies and sponsors, and improve global harmonization of the format. Therefore, it becomes crucial for the sponsors to keep up with the release of stepwise ICH updates.

Timelines for mandatory implementation of eCTD V4.0 are not yet specified for several nations such as the United States, Canada, Japan, Switzerland, Brazil, and Australia, as well as for non-centrally approved products in the European Union (EU), which further hinders prospective planning. While in certain cases, nations like Thailand, South Africa, and the region of the Gulf Cooperation Council (GCC) have not offered any plan for their V4.0 adoption. In conclusion, it appears like eCTD V4.0 deployment will be a drawn-out process that will continue to change well into the 2030s.

Why is eCTD V4.0 Efficient?

  • Enhances communication between agencies and sponsors: The upcoming eCTD version 4.0 enables two-way communication between sponsors and agencies and vice versa, which facilitates a comprehensive picture of the application's complete lifecycle, including all inquiries and information requests, in one place.
  • Harmonized information source: A single, standardized XML backbone will be used to transmit all the message's data and metadata. It would facilitate information reuse for regulated industries and more effective information exchange or evaluations for national Regulatory authorities.
  • Communication management: In eCTD V4.0, the lists of valid submission metadata (controlled vocabularies) are preserved in separate files, and the submission metadata from the XML backbone files are separated. This implies that updates or changes to the lists won't impact the backbone file. As a result, national authorities, and providers of eCTD tools benefit from simplified maintenance. It will also make updating less expensive.
  • Repurposing of the content using UUID: Each document will receive a Universal Unique Identifier (UUID) under eCTD V4.0. Future sequences can reuse the document with this identifier rather than having to submit the content repeatedly.

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Advances in the eCTD submissions can make the sponsors feel apprehensive. However, any Regulatory change should be viewed positively. This helps the sponsor evaluate their efficiency and adds sophistication to the submission plan.

Pharmaceutical manufacturers must understand that the transition from eCTD V3.2.2 to V4.0 can be a tedious affair, and hence they must collaborate with competent vendors in simplifying and streamlining Regulatory publication operations at each level of the process while adopting eCTD V4.0. Organizations can replace primitive human operations with automation, enhancing data quality and accelerating the publication of regulations to launch products faster.

Collaboration with an entrusted vendor ensures:

  • New assembly templates to support the new V4.0 structure and update Document Type Definition (DTD).
  • Updation of validation tools to ensure that all criteria, including the rules relating to the association of controlled vocabularies and sender-defined keywords, are included.
  • Provision to focus on viewing tools, ensuring the capabilities to review both the content and the structure of the eCTD V4.0 format.

The necessity to link to multiple controlled values as well as the utilization of the same list of values for both IDMP and published by organizations with integrated registrations and publishing—as well as any future initiatives requiring those same values—will be extremely helpful.

What Next?

The industry will start to gain from some much-needed reforms to the Regulatory submission procedure as eCTD V4.0 becomes a reality. This will result in streamlined approval processes and quicker patient access to new products. A seasoned Regulatory partner can help facilitate the compilation of information needed to ensure compliance throughout the lifecycle of the products being marketed. Contact us to delve into the specifics of eCTD V4.0.

Stay updated and stay informed!


Sonal Gadekar
Senior Associate


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