regulatory ectd

regulatory ectd structure

CTD Structure

The Common Technical Document (CTD) structure consists of five modules that comprise the agreed upon set of application dossier specifications for pharmaceuticals that are designed to be registered and sold in Europe, Japan, the United States, and any geographic region that utilizes the CTD structure.

The initial CTD structure was first proposed by the International Conference on Harmonisation (ICH) working committee in the 1990s before being agreed upon by participating nations in the year 2000. The U.S. Food and Drug Administration (FDA) was the first regulatory body to adopt the common CTD structure for receiving product registration submission from companies. While the processes involved in registrations have been streamlined over the years, they can be made significantly more efficient by implementing automated solutions that are specially designed to align processes and document management with the established, agreed upon CTD structure.

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Defining the Modules of the CTD Structure

Each module of the CTD structure contains unique yet essential submissions content.

  • General Information: Module 1, while technically not part of the formal CTD structure, is composed of the regional administrative and prescribing information required for the submission as well as the table of contents of the overall submission.
  • CTD Structure Summaries: Module 2, the clinical and nonclinical section, includes the table of contents of the CTD structure, the CTD introduction, the quality overall summary, the nonclinical overview, the clinical overview, nonclinical written and tabulated summaries, and a clinical summary.
  • Quality Information: Module 3 is reserved for detailed quality information relating to the manufacturer, control of drug substances, and references to standards, materials, and stability.
  • Nonclinical Study Reports: Module 4 contains compulsory safety data, including pharmacology, toxicology, and pharmacokinetics reports.
  • Clinical Study Reports: Module 5 contains efficacy information, including study reports and clinical study data.

Organizing and Managing Information According to the CTD Structure

The data required for submissions registrations in the various countries that have adopted the CTD structure is essentially the same. However, the preparation, presentation, and the depth of information that must be submitted can often vary a great deal depending on differing regional requirements. When registering new products in multiple regions, it is essential for an organization to streamline the control of documents and timelines, and to maximize the ability to track all the myriad requirements for each geographic location. To better manage these product registration processes and CTD-structured submission documentation, more and more companies are relying on software solutions to automate manual or hybrid processes.

The MasterControl Registrations for eCTD™ solution was developed to increase transparency for effective monitoring of bottlenecks, both those that exist within your organization and those involving regulatory bodies.

Challenges of Maintaining the CTD Structure and Corresponding MasterControl Solutions

Difficulty—Adhering to the CTD Structure

Manually compiling documents from the many teams involved—all of whom may use different systems—is an inefficient and painful process that often delays submissions and may seem contrary to the CTD structure.

MasterControl Solution

MasterControl simplifies the process of compiling, reviewing, and approving documents from different sources and allows all CTD-structured data to be stored in once central repository. Users are automatically notified of upcoming deadlines.

Difficulty—Adhering to the CTD Structure

Managing projects, timelines, and tracking requirements for every country is impossibly complex with mere spreadsheets. Doing so inevitably results in missed deadlines and project delays.

MasterControl Solution

MasterControl facilitates more effective document management because it maintains all artifacts related to registrations in one location. The system’s dashboards, checklists, and analytics functionality provide up-to-the-minute status of every CTD-structured project.

Difficulty—Adhering to the CTD Structure

As the number of products that must be registered in various countries increases, the variables in regional requirements grows exponentially. Keeping pace with the granularity of each registration (or re-registration) project quickly becomes overwhelmingly complicated.

MasterControl Solution

The standardized templates provided by MasterControl work right out of the box to simplify every registration project, regardless of granularity. The solution includes a built-in tool for customizing unique and complicated processes into templates that adhere to the CTD structure.

Difficulty—Adhering to the CTD Structure

Filings can be inconsistent and CTD structure submission data can become fragmented when different teams are all focusing on customizing registrations to different markets.

MasterControl Solution

MasterControl provides a single platform for a holistic approach to submissions. The solution’s templates and checklists are based on CTD structure standards to facilitate consistent filings throughout your organization, regardless of region.

Difficulty—Adhering to the CTD Structure

It is all too easy to get stuck in minutiae and lose the vision of critical deadlines when your organization has multiple products that need to be registered in a variety of countries.

MasterControl Solution

MasterControl’s advanced tools provide both a macro and micro view of all your registrations projects. The solution allows you to easily zoom in on requirements of particular countries or zoom out for a global view of all markets.

Difficulty—Adhering to the CTD Structure

Communication challenges and the inability to provide timely response to regulatory issues are unavoidable when stakeholders are all using disparate systems.

MasterControl Solution

MasterControl Registrations for eCTD integrates with the quality management or other systems to facilitate collaboration.

Benefits of MasterControl to Companies Complying with the CTD Structure

MasterControl Registrations for eCTD allows companies to:

  • standardize registrations processes;
  • increase efficiency;
  • manage milestones effectively;
  • improve connectivity; and
  • enhance project visibility.

Learn More about CTD Structure and MasterControl Solutions

To learn more about the CTD structure or MasterControl solutions that are designed to simplify and streamline registrations processes, contact a MasterControl representative today.
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