What is eCTD submission format?

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 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?

The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. The primary technical components are: A high level folder structure (required) An XML “backbone” file that provides metadata about content files and lifecycle instructions for the receiving system.

What is metadata in eCTD?

Data about the data content. For example, when you submit certain eCTD quality documents, you are required to provide the dosage form and strength of the drug product. Call this descriptive metadata. This equates to the album and track data for your music.

How do you prepare eCTD?

Submit Using eCTD

  1. Learn About eCTD.
  2. Review the Electronic Submission Resources.
  3. Submit Fillable Forms and Compliant PDFs.
  4. Request an Application Number.
  5. Register for an Electronic Submissions Gateway Account.
  6. Send a Sample Submission to FDA.
  7. Submit Via the Electronic Submission Gateway.

What is eCTD compliance?

The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

What is different modules in eCTD?

Module 1 (not technically part of the CTD): region-specific administrative information. Module 2: manufacturing, nonclinical, and clinical overviews and summaries. Module 3: detailed manufacturing information. Module 4: nonclinical study reports. Module 5: clinical study reports.

What is eCTD leaf title?

Leaf Title The eCTD content is made up of multiple files. The eCTD contains a “” element for each of these files. The leaf title is used to easily identify the file when using a dynamic table of contents or eCTD review tool.

What is eCTD publishing tool?

eCTD publishing is the final compilation of regulatory documents as an electronic submission and typically includes: Assignment of documents to a location within the eCTD modular structure. PDF rendering of the final, hyperlinked documents. Customisation of document headers and footers.

What is the difference between CTD and eCTD?

CTD and eCTD Submission • CTD (Common Technical Document):- is a harmonized format for submission of detailed information on medicines to regulatory authorities and agencies for the purposes of obtaining approval to market a product. eCTD (Electronic Common Technical Document): is the electronic version of CTD.

What is eCTD in pharmacovigilance?

eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health Authorities (HAs). It provides a harmonized solution to implement the Common Technical Document (CTD) electronically.

What is node in eCTD?

Node Extension Node extensions are a way of providing extended organisational information in the eCTD. The node extension should be visualised as an extra heading in the CTD structure and should be displayed as such when the XML backbone is viewed.