eCTD  Module 1

What You Need to Know about Electronic CTD Module 1

The electronic Common Technical Document (eCTD) standard format is designed to harmonize submission of data and information by pharmaceutical companies to regulatory agencies. The eCTD organizes information based on sections, documents, and eCTD modules1 through 5. Strictly speaking, eCTD module1 is not “common” in the sense that it’s region-specific and varies for every region.

Module 1 describes the administrative and prescribing information, such as the product information and labeling required by local regulators. For example, Australia’s Therapeutic Goods Administration (TGA) sets its own requirements for dossier format and content for eCTD module1.

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