The electronic common technical document (eCTD) is the principal digital format pharmaceutical companies use to register drugs from human use with a regulatory agency as adopted by the International Conference on Harmonisation (ICH). The eCTD dossier is the collection of files, data and information that are required to be contained in an eCTD drug submission by a regulatory body. An eCTD dossier is more commonly called a new drug application (NDA) in the U.S. and a marketing authorization application (MAA) in the European Union and other countries.
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eCTD Dossier preparation is the process of compiling, maintaining and presenting in eCTD format the entirety of a pharma company’s technical data about a particular drug’s clinical studies, medical safety and efficacy trials, medicinal product quality, analytical testing, and other related information prior to the eCTD’s official submission to a regulatory agency. To create an effective eCTD dossier that will pass muster with the regulator, it must be checked for accuracy and appropriate version history prior to submission. This process helps ensure that all documentation for the application drug’s quality, efficacy and safety properties suitable for intended use have been included in the eCTD dossier.
Before you can submit an application or eCTD dossier to the FDA, you will have to request a pre-assigned c application number. Prior to requesting an application number, you must apply for a secure email with the FDA by contacting firstname.lastname@example.org. There are separate email addresses for both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) based on the your respective product type. Follow the complete instructions on how to get your eCTD application number on the FDA’s Submit Using eCTD website, under step number four, Request an Application Number.
In recent years, the FDA has made a complete transition from paper-based dossier applications to a fully digital submission process.
MasterControl’s eCTD dossier publishing solution confirms that CTDs are submitted in the standard eCTD format that regulatory agencies require. It also enables users to generate submission-ready documents, and control, track and collect files within the system’s centralized and integrated electronic platform.
MasterControl and its partner, i4DM, have served as the quality management system (QMS) providers for the FDA’s Office of Regulatory Affairs since 2009. They also serve as QMS providers for the Division of Pharmaceutical Analysis, part of the FDA’s Center for Drug Evaluation and Research (CDER).