regulatory ectd

regulatory ectd ich


The ICH CTD is a common format used for the preparation of a well-structured Common Technical Document (CTD) for applications that will be submitted to regulatory authorities.

The International Conference on Harmonization (ICH) – in collaboration with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Ministry of Health, Labour and Welfare – developed the CTD application dossier format for regulatory submissions. The ICH CTD serves as participating countries’ regulatory compliance guideline for new drug applications.

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The Origin and Composition of the ICH CTD

The internationally agreed upon “well-structured common format” of the ICH CTD is a set of specifications for a dossier for the registrations of medicines. Dossiers organized according to the technical requirements of the ICH CTD may be submitted to the appropriate regional regulatory authority as an application for the registration of pharmaceuticals intended for human use in the regions that recognize the ICH CTD format (specifically, the U.S., Europe, and Japan).

While ICH CTD submissions were initially delivered exclusively in paper form, the proliferation of technology has propagated the now more prevalent electronic format of the Common Technical Document, ICH eCTD. As the administrative agency over the current form of the CTD, ICH is responsible for steering and administering any future changes to the ICH CTD harmonized guideline.

The ICH CTD is structured in five distinct modules:

  • Module 1, while technically not part of the categorical ICH CTD, contains administration information particular to regionality. All ICH CTD submissions contain this module that includes all the basic information pertaining to the application, country/agency, submission type, and so forth.
  • Module 2 consists of summaries and overviews of the clinical and non-clinical sections of the ICH CTD.
  • Module 3 details the quality information pertaining to the manufacturer, control of drug substances, references to materials and standards, and the like.
  • Module 4 is reserved for safety information and includes toxicology, pharmacology, pharmacokinetics, and similar reports.
  • Module 5 contains efficacy data, study reports, and clinical study data.

MasterControl Registrations Helps Companies Ensure ICH CTD Compliance

Maintaining documentation according to the ICH CTD format requirements can be laborious and stressful. While the essential required information may be the same for registrations in countries that have adopted the ICH eCTD standard, the preparation, delivery, and complexity of the information may vary greatly according to regional requirements.

To alleviate these concerns surrounding the ICH CTD and streamline submissions management processes, MasterControl provides preconfigured, building-block templates that are based on the ICH CTD standard that allows companies to quickly launch registration projects in accordance with regulatory guidelines. These templates are included in the MasterControl Registrations for eCTD™ software solution, which has been expertly designed to help life sciences companies automate processes and meet ICH CTD requirements. The Registrations for eCTD solution is a holistic system for product registration and ICH CTD submission management that will automate your processes and streamline the control of essential documents and critical timelines.

Benefits of an ICH eCTD Submissions Management Software Solution

Consider the value of an ICH CTD submissions management solution that can:

  • automate manual processes and simplify the process of compiling, reviewing, and approving ICH CTD documentation from disparate sources;
  • maintain all ICH CTD artifacts in a central location for maximum document management effectiveness;
  • provide checklists, analytics, and dashboards that provide real-time visibility into the status of every project;
  • simplify every product registration – regardless of granularity – through the use of standardized, out-of-the-box templates;
  • provide a powerful tool for configuring complex and/or unique processes into templates;
  • promote consistent filings throughout your organization, regardless of location, with templates and checklists that are based on industry standards and best practices;
  • empower users with the ability to view ICH CTD activities on a micro view by country or a macro, global perspective;
  • facilitate collaboration by integrating other enterprise systems, such as a quality management system (QMS); and
  • provide a single platform for a unified approach to ICH CTD submissions.

What is Your Strategy for ICH CTD Readiness?

Exactness in the preparation of the various modules that comprise an ICH CTD submission and rigorous supervision of the myriad projects that are involved in CTD activities can be incredibly challenging, but are necessary for the submission to succeed. At minimum, a strategy for ensuring the ultimate success of an ICH CTD submission will entail the following key components:

  • Efficiency of product registration and ICH CTD submission management processes
  • Adequate control of ICH CTD documents and timelines
  • Effective tracking of the various requirements pertaining to every relevant geographic location
  • Maximal project transparency and effective monitoring of bottlenecks, both within your organization and with associated regulatory bodies

The MasterControl Registrations for eCTD software solution can provide the structure for a successful ICH CTD submission strategy and help get your products to market sooner in the geographic locations you are targeting. It eliminates the painful process of manually compiling ICH CTD documents from multiple sources and disparate systems, which increases efficiency and prevents delays in submissions. It negates any need to manage timelines and tracking requirements by spreadsheets, an inefficient practice that can often result in missed deadlines and delays. The solution also ensures that collaboration is effective and that filings are consistent.

For More Information About ICH CTD

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