regulatory ectd

regulatory ectd module-1

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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ICH CTD Module 1

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.

How MasterControl’s Regulatory Excellence Solutions Can Help You

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

  • Document Control and Management: If your organization still uses binders, spreadsheets, and other manual tools to manage your content, MasterControl can automate your processes for a more effective document control and management. It will automate the entire document lifecycle, from routing through follow-up, escalation, and approval. Automation will facilitate stakeholder participation in compliance processes by providing a single, centralized repository for all submission artifacts.

  • Visibility of Product Registration Projects: Make it easier for users to complete their tasks by making their registration projects visible. With MasterControl Registrations for eCTD, you can! Users will be able to easily identify the countries where each of your product is being registered. Similarly, they will be able to see all your products up for approval in every geographic location.

  • Content Repurposing: Apart from eCTD Module 1, which is regional, most of the other contents must be repurposed. MasterControl’s best-practice templates will help you standardize your registration projects across the board and help minimize errors resulting from inconsistent filings.

  • Collaboration of Different Teams: A manual system allows only linear collaboration, which means different teams must take turns in reviewing, editing, and approving a document. If a team member is sick or on vacation, the collaboration may come to a standstill. You can say goodbye to all that with MasterControl, which will provide you with a virtual collaboration workspace 24/7. It will allow the different teams to work together simultaneously and in real time.

  • Milestone Management: Still relying on spreadsheets to manage project milestones? A spreadsheet doesn’t scale to the complexities of requirements, changes, and timelines involving multiple countries. You need to be able to update and amend your artifacts immediately when changes occur. MasterControl will equip your stakeholders with powerful tools, such as dashboards, checklists, analytics, to manage milestones and keep up with changes.

  • Connected Platform: Most pharmaceutical companies use different systems to manage the dossier compilation process. Some publish documents in-house, while others outsource the work to a regulatory vendor. Regardless of your process, you need to be able to connect your in-house teams, remote employees, outside consultants, and suppliers. MasterControl can serve as your compliance platform. It can help you integrate different systems and the teams that use them.

Learn More About MasterControl Registrations for eCTD

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.

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