Simplifying Global Submissions with eCTD 4.0

Electronic Common Technical Documents (eCTD) was introduced in the late 1990s to streamline the regulatory submission process across diverse regions. Before eCTD, the process of submission of regulatory information involved manually printing and submitting paper documents, making the process tedious and time-consuming. In the 1990s, it was the time that International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) established the ICH M4 Expert Working Group/Implementation Working Group, which created the Common Technical Document (CTD) to standardize the submission of applications to regulators. It was a collaborative evolution involving regulatory bodies and experts to meet modern digital needs. This led to the transformation of the traditional paper-based CTD into the eCTD, to improve workflows, improve data management practices, and enable faster reviews by regulatory authorities. The first edition, eCTD 3.0, was approved in 2003 and version eCTD v3.2.2 was launched in the year 2008.?

The eCTD v3.2.2 version has several shortcomings that reduce the efficiency of submissions. The use of multiple XML files, which include distinct ones for different studies and regions, adds unnecessary complications. Additionally, the requirement of resubmitting the same document for each step is redundant and time-consuming. The system's method of replacing one document entirely with another lacks the nuance needed for effective content management. Addressing these shortcomings is essential to streamline the regulatory submission process and enhance its overall effectiveness.?

How eCTD Simplifies Global Submissions?

The newer version eCTD 4.0 brings several advantages that directly address these challenges faced by previous versions:?

• Harmonized Submission Format: To simplify and ensure consistency during submission processes, eCTD 4.0 utilizes one single XML message as opposed to multiple regional and ICH messages for submissions. However, while the fundamental framework is unified, regional variations still exist- local regulatory authorities often require additional data to meet their requirements.?

• Document Reuse: eCTD 4.0 allows for document reuse across multiple submissions, making the compilation and submission of regulatory information much faster and simpler. eCTD assigns each document a Universal Unique Identifier (UUID), so future sequences don't have to resubmit identical content again.?

• Life cycle Management: A more advanced lifecycle management system enables better monitoring and management of document versions throughout the submission process.?

• Controlled Vocabularies: eCTD 4.0 implements controlled vocabularies to ensure consistent terminology across submissions, providing for easier communication between sponsors and regulatory authorities.?

• Enhanced Data Management: For ease and consistency in content organization and retrieval, modules 1--5 content is now contained within one unifying exchange message, stored as an XML file for easy organization. eCTD 4.0 includes more precise metadata, which helps better categorize and retrieve submission documents.??

• Two-way communication: eCTD 4.0 allows for two-way communications between regulatory authorities and sponsors to ensure everyone remains on the same page during submission processes. This helps improve interactions between regulatory authorities as well as sponsors. However, this feature is intended to supplement the overall submission process rather than replace direct communications or formal regulatory review meetings.?

Conclusion?

The adoption of eCTD 4.0 addresses previous limitations and improves communication between sponsors and regulatory authorities, leading to greater efficiency and automation. As the regulatory landscape continues to evolve, the advancement to simplify eCTD submissions have brought greater efficiency, automation, and global harmonization. The US FDA began supporting electronic eCTD 4.0 submissions?for new applications on September 16, 2024. Japan's Pharmaceuticals and Medical Devices Agency plans on making it mandatory by 2026. Future advancements may include AI-powered validation tools, compliance checks, and real-time tracking of submissions.?

To navigate the evolving regulatory landscape eCTD 4.0 submissions, it’s essential to partner with experienced regulatory experts. Contact us today to learn how our eCTD publishing services can assist you in transitioning seamlessly to eCTD 4.0.?

At DDReg, we provide eCTD publishing and submission services. DDReg’s team of experienced regulatory professionals is well-versed in regulatory requirements and guidelines from health authorities, ensuring that all submissions comply with the latest regulatory standards. For professional advice and assistance in regulatory-related queries, get in touch with us at https://www.ddregpharma.com/contact-us???

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