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Blog
Preparing for the new and improved eCTD regulatory submission standard
Sadia Ahmed, Product Manager, Regulatory Technology
Jan 23, 2023

The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements and other regulatory reports. These are submitted to Health Authorities around the world, such as the U.S. FDA, Canada’s Health Canada, the EU’s EMA, and Japan’s PMDA. The eCTD is celebrating its 20-year anniversary as the required format for most submissions to regulatory bodies.

The first version of eCTD 3.0 was finalized in 2003, and while it has provided significant productivity benefits to both health authorities and the industry, additional improvements are needed to address evolving requirements in several key topic areas.

After years of collaboration across regulators and industry sponsors, a new major version of the eCTD v4.0 is now ready for implementation, and it promises to finally meet some of the critical needs in the regulatory operations process. Let’s dive into what it is and how implementation can be a delicate process.

What is new in eCTD 4.0?

The eCTD 4.0 standard aims to improve robustness, flexibility and long-term stability compared to previous versions. It creates a significantly more advanced life cycle management process. All regions that have adopted eCTD 3.x standard are either already accepting eCTD 4.0, i.e. Japan, or planning their pilot and transition period for 2023 and beyond, looking to make this standard mandatory by 2028 for most.

The new standard is a more flexible solution built on data-driven standards: It will be extremely beneficial for regulatory submissions, and these benefits include:

  • Single format to be used for all regions/agencies/centers
  • Single format for all types of products, i.e., drugs, veterinary, med devices, cosmetics, tobacco, food additives, etc.
  • Reduce structural changes and software release cycles for vendors, sponsors, and agencies
  • Better reuse of documents with unique identifier
  • Flexible Lifecycle Management i.e., replacing one document with many, or vice versa
  • Ability to prioritize document/studies thru application lifecycle
  • Two-way Communication between agencies and sponsors

How to get started with implementation

There are many key considerations while implementing eCTD 4.0; The people, plan, process, and technology all involved can make or break the process. In order to best prepare, there are a few things organizations should know, such as eCTD 4.0 cannot be easily manipulated manually. Prior to the new standard, all PDFs should be prepared as submission-ready to ensure a smooth transition. Training internal staff on all terminology and concepts as well as familiarizing teams with the latest ICH and regional specifications and guidelines for the new standard will help in streamlining submission processes. Until eCTD 4.0 is mandatory across the board, continued support of eCTD 3.x is required in tandem. Without the proper foundation for the new standard, organizations will fall behind on necessary regulatory procedures.

Organizations need to prepare and begin the implementation to the eCTD standard. The changes promise to meet the critical needs in the regulatory operation process, but to get there, careful implementation and review of the differing regional requirements are needed.

For more information on how best to prepare to eCTD 4.0, please visit this page on how automation supports the shift, or send a note to RegulatoryTechnology@iqvia.com.

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