What is eCTD FDA submission?
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).
What eCTD viewer does FDA use?
GlobalSubmit VALIDATE is used exclusively by FDA to assess the technical validation criteria of all eCTD submissions passing through its Electronic Submissions Gateway, confirming compliance standards are met.
Is eCTD mandatory?
Yes, eCTD format has been mandatory for new national MAAs since 1 July 2018 and from 1 January 2019 for all other submission types, in line with Annex 2 of the HMA eSubmission Roadmap. 2.
What is the current version of eCTD?
The current version of the eCTD specification to be used for CTD modules 2-5 is the Electronic Common Technical Document Specification V3. 2.2 (PDF). More information about the standard can be found at the ICH eCTD webpage.
What is eCTD structure?
An eCTD consists of individual documents in PDF format which are arranged in a hierarchical form as per the CTD structure. It also has an XML backbone which cross-links required documents and provides information regarding the submission.
What are the different modules in eCTD?
Pharmaceutical point of view The eCTD has five modules: Administrative information and prescribing information. Common technical document summaries. Quality.
What is eCTD dossier?
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.
What is CTD file?
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.