What is an Electronic Common Technical Document?

What is an Electronic Common Technical Document (eCTD)?

Electronic Common Technical Document (eCTD) is a standardised format for submitting regulatory information related to human, medical device , or veterinary medicinal products to Regulatory Health Authorities. This format is mandated by the International Council for Harmonisation (ICH), reflecting a global effort to streamline and harmonise the process of drug application submissions.

CTD vs eCTD

The eCTD itself is an electronic submission format which consists of various documents arranged hierarchically on the basis of Common Technical Document (CTD) structure. It incorporates an XML backbone that links these documents together and provides submission related information. The primary goal behind introducing the eCTD format is to ease the burden on authorities reviewers and simplify the submission process by offering an electronic version of the CTD. To ensure submissions to authorities it is crucial to follow the eCTD format diligently. This task can be quite complex especially when multiple contributors are involved, and strict deadlines must be met.

eCTD Modules

The eCTD is organized into the five modules that serves a specific purpose in communicating medicine or drug-related information to regulators. The modules are as follows:

Module 1: Administrative information

Module 2: Clinical, non-clinical, and quality summaries

Module 3: Quality

Module 4: Non-clinical study reports

Module 5: Clinical study reports

eCTD submissions are valid for applications including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Investigational New Drug (INDs), Master Files (MFs), and Biologics License Applications (BLAs) associated with these applications.

Many major countries such as the US, Europe, Canada, Australia, Thailand, Japan and South Africa have adopted eCTD as the submission format due to its advantages over traditional methods. These benefits encompass the automated uploading of sequences via the XML system referencing for reviewers through hyperlinks removing the necessity of scanning or storing documents, effortless identification of modifications and updates to dossiers, streamlined tracking of product life cycles and the ability to access documents simultaneously.

Despite the many advantages that the eCTD brings, it can also be associated with several challenges. These include transition from paper-based submissions to electronic submissions, the need for standardization across regulatory agencies, complexity of the eCTD structure and granularity, and interoperability among others. Therefore, partnering with regulatory consultants that bring experience and global agency knowledge can help navigate such obstacles that can hinder eCTD submission.

DDReg’s Capabilities

eCTD submission to global regulatory agencies through web portal or gateway

Dossier conversions- paper-based to NeeS to eCTD

Dossier conversions- paper-based to NeeS to eCTD

Comprehensive support through dossier lifecycle i.e., publishing, submission, archival

End-to-end publishing support across initial applications, query responses, variations while maintaining product-specific filing sequence

Supporting eCTD submission management through web-based proprietary tool, VITALIC®