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