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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In the United States, the Food and Drug Administration considers eCTD module1 the backbone file for specifications. It includes very specific instructions, down to the use of bold italic font for elements and attributes. Given the regional variables, eCTD module1 is the only module that can’t be harmonized.
Since the International Council on Harmonisation (ICH) is the organization that led efforts to create “CTD Module 1,” the module name is often used interchangeably with “ICH Module 1.” Both namesakes, however, refer to the same requirements. ICH Module 1 requirements vary by geography, though Modules 2, 3 4 and 5 are internationally harmonized. Companies generate and must effectively manage a substantial number of eCTD pharma documents as each module’s requirements are met. Said documentation should be readily available to the appropriate regulatory bodies.
Product registration requires a complex compilation of information coming from various functional areas. If your organization still uses binders, spreadsheets, and other manual tools to compile your content, MasterControl can help you accelerate time to market by automating your processes.
The eCTD standard format is meant to harmonize the submission process throughout the world, and yet regional elements in product registrations remain. As a result, sponsors and contract research organizations must repurpose submission content to comply with regional requirements.
MasterControl Registrations for eCTD can help you streamline the creation, compilation, and management of dossier content and avoid the challenges common in manual processes. The cloud-based solution can help you in the following essential areas
MasterControl is the software provider for major U.S. federal and state agencies, including divisions of the world’s largest and most recognized regulatory agency, have chosen MasterControl as their software provider. For more information about MasterControl Registrations for eCTD, contact one of our representatives. To learn more about eCTD Module 1 and other Modules, visit the ICH website.