eCTD Guidelines

Following electronic Common Technical Document (eCTD) guidelines significantly reduces the time and resources required for compiling applications for registration of pharmaceuticals.

The eCTD guidelines are the set of specifications for a dossier for the registrations of medicines. As the common format agreed upon by the governing regulatory bodies in Europe, Japan, and the U.S., the eCTD guidelines serve as the technical requirements for submissions of applications to register pharmaceuticals for human use in those regions. A comprehensive and well-prepared eCTD guideline-adherent regulatory application is essential to smooth approval and registration processes and extremely beneficial in getting products to market sooner.

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Practical Purpose of the eCTD Guidelines

The eCTD guidelines, spelled out in the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use, is not intended to indicate specifically required studies. Rather, the ICH Harmonized eCTD guidelines merely indicate an appropriate format for the data that have been acquired. The overall organization of the eCTD should not deviate from that which is outlined in the standard. According to the eCTD guidelines, the display of information should be unambiguous and transparent so that basic data can be readily reviewed and allow reviewers to become quickly oriented to the contents of the application.

Software that Simplifies Adherence to eCTD Guidelines

For pharmaceutical, biotech, and other life sciences companies, the registration of products follows immediately after a demanding regulatory approval process. And registering a new product in different countries is a complex, often protracted, and anxiety-fraught endeavor. Given that the drug development process itself has taken 10 to 15 years, these companies are already under the gun to get their drug products on the market and start achieving a return on their investments.

If your organization has been involved in registering pharmaceutical products before, you are undoubtedly familiar with these challenges that are commonly faced when attempting to follow eCTD guidelines:

  • Manually compiling documents that are generated from myriad sources and systems (i.e., PLM, ERP, etc.) is an inefficient and painstaking process that ultimately leads to delayed submissions.
  • Deadlines are missed because managing timelines and tracking requirements for all countries in which registration is sought can be an impossible task when using spreadsheets that don’t scale to the complexities required by CTD guidelines.
  • Keeping pace with the granularity of every registration is overwhelming as the variables in eCTD guideline requirements increase exponentially relative to the number of countries and number of products being registered.
  • The use of disparate systems leads to communication breakdowns and an inability to provide timely response to issues relating to eCTD guidelines.
  • Filings can be inconsistent when different teams are focused on customizing registrations to each market, causing submission data to be fragmented across multiple systems.
  • When multiple products need to be registered in many countries, it is easy to become mired in minutiae and lose visibility into eCTD-guideline-critical activities and deadlines.

The MasterControl Approach to Meeting eCTD Guidelines

Although the eCTD guidelines help companies avoid the need to generate and compile different registration dossiers, the tracking and document management components of the registration process are far too complex to handle with manual systems. To help alleviate the pains commonly associated with following the eCTD guidelines for registrations, MasterControl has designed a preconfigured building-block solution that allows companies to rapidly launch myriad registration projects in accordance with CTD guidelines. The MasterControl Registrations for eCTD™ software solution helps companies automate processes and meet the requirements of eCTD guidelines. The solution has been expertly designed to help life sciences companies streamline their control of critical timelines and essential documents.

Some of the features that allows users of MasterControl Registrations for eCTD to align with eCTD guidelines include:

  • Preconfigured Templates: MasterControl’s building-block templates are based on eCTD guidelines to help companies launch their registration projects fast. The Registration Template provides an indispensable structure regardless of regulatory or regional variables and includes a tool for customizing discrete processes into standardized templates for every country. A notification Template provides a framework for notifying various departments and stakeholders about tasks or approaching deadlines.
  • Checklists: This basic safety mechanism to help avoid eCTD guideline requirements from being overlooked and tasks from falling through the cracks can be customized based on country.
  • Easy-to-use Explorer Tool: MasterControl allows users to organize, find, and access documents quickly and create shortcuts to frequently used documents and readily view metadata and native files.
  • InfoCards: These fundamental tools for creating, searching, and retrieving documents serve as placeholders for documents in the database so they can be readily identified and summarized.
  • Dashboard: This robust tool consolidates charts to provide users with a view of a lot of data in on one consolidated page.
  • Reporting and Analytics: MasterControl’s metrics capabilities allow users to generate both standard and custom reports that can be drilled down according to your business needs.

Learn More About eCTD Guidelines

To learn more about eCTD guidelines or MasterControl’s Registrations for eCTD solution, contact a MasterControl representative.

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