regulatory ectd

regulatory ectd dossier

What is an eCTD Dossier?

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.

10 Common Pains in Dossier Management & Product Registration

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What is eCTD Dossier Preparation in Pharma?

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.

FAQs About the eCTD Submissions

  • Why submit an eCTD Dossier? Submitting an eCTD dossier for a medicinal product application to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), is part of the legal drug approval process required by a pharmaceutical manufacturer in order to launch the drug on the market in that agency’s jurisdiction.

  • How can I find out if my company’s eCTD dossier meets FDA requirements? For complete details on how to meet the eCTD requirement, refer to the FDA’s eCTD Guidance.

  • Where can I learn more about the actual eCTD dossier submission process? For a list of resources and a breakdown of the individual steps reviewers will need to follow for an eCTD dossier submission to the FDA, visit the agency’s Submit Using eCTD page.

  • What other information and data points do eCTD Submissions include? eCTD dossiers typically also include information about the drug’s ingredients and if its labelling and packaging are appropriate. It should also have the details of the methods used to manufacture the drug (e.g., Good Manufacturing Practices [GMP]), the controls used to maintain its quality and to preserve the drug’s identity, strength, quality and purity.

What is an eCTD Application Number?

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 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.

Why Are eCTD Dossiers Submitted Electronically to Regulatory Agencies?

In recent years, the FDA has made a complete transition from paper-based dossier applications to a fully digital submission process.

  • As of 2017, the FDA requires that medicinal applications be submitted electronically with an eCTD as the standard format.

  • All dossier applications, including for new drugs, amendments, supplements and reports, must use eCTD for submissions.

  • The eCTD is also the accepted format for new drug submissions for the European Union’s European Medicines Agency (EMA), Australia’s Therapeutic Goods Administration (TGA), Health Canada, and Japan and China’s respective regulatory bodies.

MasterControl’s eCTD Dossier Solution

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 the FDA

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).

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