eCTD 4.0: The evolution of regulatory submissions

G&L Regulatory Affairs Manager, Phil Kerr, examines the revised eCTD regulations, shedding light on their significant implications for the approval process.

Purpose:

The electronic Common Technical Document (eCTD) stands as the gold standard for regulatory submissions.

The latest iteration to be introduced by the International Committee for Harmonisation (ICH), eCTD 4.0, contains several new or improved features designed to:

• Redefine and improve communication between health authorities and applicant pharmaceutical companies.

• Increase efficiency in the regulatory approval process.

• Facilitate digital transformation for greater interoperability.

• Act on feedback received from requirements of previous versions.

• Ensure enhanced data quality and integrity.

• Strengthen security and confidentiality.

Evolution:

Building on these principles, let us delve into the key changes from the previous eCTD version (3.2.2):

• Communication changes with the introduction of a two-way logical sequence flow, facilitating seamless interactions between health authorities and pharmaceutical companies.

• Improved transparency is achieved through a coherent flow of information, encompassing all documents in the eCTD sequence.

• Controlled vocabularies are introduced to establish consistent terminology across health authorities, applicants, and the ICH.

• XML documents, once accessible via web browsers, now require specialized software for viewing and enhancing security measures.

• Document navigation is streamlined thanks to the adoption of a flat structure with keywords, and the consolidation of XML files simplifies the overall review process.

• Enhanced encryption protocols and user authentication mechanisms strengthen security and confidentiality.

Implementation:

The voluntary use of these changes was established in 2023, with countries such as Brazil directly introducing version 4.0.

However, widespread adoption will occur gradually due to associated costs and training requirements, and some may choose to wait until the requirements become mandatory.

Information is correct as of 29 November 2023. Dates may be subject to change.

Conclusion:
The harmonization and digital transformation brought about by eCTD 4.0 represent a positive step forward.

By streamlining communication and processes, this evolution is poised to increase efficiency and foster collaboration.

As the industry adopts these changes, eCTD 4.0 sets a standard for a more standardized and collaborative future in regulatory affairs.

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