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Creating a Compliant eCTD: Avoiding Common Regulatory and Technical Pitfalls on the Path to Submission

The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to the Food and Drug Administration. The eCTD harmonizes the regulatory review process for global drug development, as its structure is based on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines.

In addition to streamlining the review process for the FDA, the eCTD format simplifies the submission process for sponsors because it uses the same format employed by regulatory agencies in other countries. However, failure to comply with its regulatory and technical requirements could jeopardize the success of your submission and your product development plan as a whole, especially for early-stage biotech companies working with limited resources. Here are strategies for avoiding some of the most common electronic publishing pitfalls on the path to submission.

Have the right people, processes, and technology

The transition to a fully digital submission process requires coordination across many functional areas. While an eCTD can be built manually, this is a long and tedious process. There are many integrated document management and publishing software tools that can be used to automate the process, but technical expertise and extreme attention to detail are still essential. For instance, if you choose to use eCTD publishing software or viewing software, you should include time in your submission timeline for selection, setup, validation, compatibility checks, training, and maintenance, or partner with a regulatory services provider who can help you make the best decision for your needs.

Perhaps most important, successful eCTD submissions require knowledge and understanding of the current eCTD Submission Standards, which are updated periodically, and other local and global regulations and requirements.

Know the current technical requirements

eCTD submission requires strict compliance with the Comprehensive Table of Contents Headings and Hierarchy and eCTD Submission Standards catalog, and with very detailed technical requirements. These requirements range from formatting specifications and hyperlinking to metadata requirements and folder- and file-naming conventions. The FDA uses a commercial, off-the-shelf product to validate eCTD submissions according to its published specifications for eCTD Validation Criteria.

According to the FDA, the top reasons eCTD submissions get rejected include:1

  • Receipt of duplicate sequence submission
  • Mismatch between the application number in the us-regional.xml and the application number on the FDA form
  • Submission sent to the wrong center
  • Submission of corrupted or broken media
  • Failure to use standard eCTD format

Develop templates or guidelines

Developing templates or guidelines on how to format, write, and prepare documents helps ensure a cohesive application and may help limit the time required for publishing documents in eCTD format. An experienced regulatory services partner will already have templates and guidelines in place for your use, saving the time and costs involved with developing these yourself.

Allow sufficient time for your submission

Last-minute content changes in final documents can have a ripple effect on the entire submission and lead to delays. Using integrated document management and publishing software can be especially valuable in ensuring that your submission allows sufficient time to create technically compliant eCTD documents. Most e-submission management software solutions also include validating systems that will identify validation errors, further minimizing the risk of submission rejections.

To learn more about eCTD submissions and the requirements for technical conformance, refer to Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, revised in February 2020, and the eCTD Technical Conformance Guide, last updated in December 2019.

Premier Consulting has been a trusted eCTD vendor for small to midsize pharmaceutical, biopharmaceutical, and medical device companies since 1995. Learn more about our services and get in touch with our electronic publishing team.