The Common Technical Document (CTD) is an internationally agreed upon format required by regulatory authorities for well-structured dossier applications for the registrations of medicines. The International Conference on Harmonization (ICH) developed the CTD regulatory submissions format in collaboration with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Ministry of Health, Labour and Welfare. As the administrative agency over the current form of the CTD, ICH is responsible for steering and administering any future changes to the harmonized CTD guideline. A CTD file, a term that refers to any required and relevant document, file or piece of information that is required to be included in the dossier application, must be indexed into one of the five modules that comprise the CTD (or its electronic counterpart, the eCTD).
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The CTD document and dossier specifications serve as participating countries’ regulatory compliance guidelines for new drug applications. In the regions that recognize the CTD regulatory file format (specifically, the U.S., Europe, and Japan), CTD files are organized into dossiers that align with prescribed technical requirements for eventual submission to the appropriate regional regulatory authority as an application for the registration of pharmaceuticals intended for human use. As illustrated in the accompanying CTD triangle, all well-structured CTDs are divided into five distinct modules that contain the proper arrangement of CTD files
While Module 1 of the CTD is region specific, the other CTD sections (Modules 2, 3, 4 and 5) are common for all geographical regions. While the essential CTD regulatory information may be the same for registrations in countries that adhere to the CTD file-structure standard, the preparation, delivery and complexity of the information may vary greatly according to regional requirements.
Maintaining paper-based documentation according to the format requirements for common technical documents can be laborious and stressful. This reality led the ICH and united regulatory authorities to upgrade the original CTD document structure in February 2002 in the form of Version 2.0 of the eCTD. Regulatory agencies continue to lead the wider industry’s inclinations toward maximum electronic management of common technical documents. In fact, as of 2017, the FDA has mandated the electronic submission of all applications and the eCTD is now deemed the standard CTD file format.
Switching from paper to electronic systems for CTD document management helps eliminate many common CTD file management obstacles, such as:
With the permissibility of submissions in NeeS (Non-eCTD Electronic Submission) formats ending in 2018, the eCTD will be the only accepted CTD file format for new drug submissions by the European Union’s European Medicines Agency (EMA) moving forward. The EU CTD format is the same as the standard CTD document formatting scheme for submissions in other geographies, with the possible exception of Module 1 (which contains region-specific administrative information for all common technical documents). To see the current EU CTD regulatory requirements for Module 1, visit the EU CTD Module 1 specifications page.
As with other regions and regulatory authorities, a strategy for ensuring the ultimate success of an EU CTD submission to EMA entails the following key components:
To help companies alleviate common CTD file management concerns and streamline their submissions-related processes, MasterControl provides submissions management software solutions that are specifically engineered to facilitate adherence to the CTD regulatory standard. By including templates that have been expertly designed to help life sciences companies automate processes and meet CTD regulatory requirements, MasterControl Regulatory Excellence solutions allow companies to quickly launch projects that are harmonized with regulatory standards. MasterControl Regulatory Excellence is a holistic system for CTD submission management and product registration that will automate your processes and streamline your control of essential CTD documents and critical timelines.
MasterControl provides the basic structure for successful CTD file management and helps get your products to market sooner in the geographic locations you are targeting. It eliminates the painful process of manually compiling CTD documents from multiple sources and disparate systems, which increases efficiency and prevents delays in CTD regulatory submissions. MasterControl negates any need to manage timelines and tracking requirements using spreadsheets, an inefficient practice that can often result in missed deadlines and costly delays.
Exactness in the preparation of the various CTD sections that comprise a submission (not to mention the rigorous supervision of the many projects involved in generating and maintaining CTD documents and activities that is involved) can be incredibly challenging but is nonetheless necessary if a submission is to succeed. The Regulatory Excellence solution ensures that collaboration on the various CTD sections is effective and that filings are consistent.
To learn more about CTD files or MasterControl’s Regulatory Excellence solutions, contact a MasterControl representative.