What are eCTD requirements?

What are eCTD requirements?

An eCTD submission has five modules: region-specific information, summary documents, quality-related information, nonclinical study reports, and clinical study reports. When materials are submitted electronically, it is easier for FDA to review data, approve new drugs, and monitor drugs after they go on the market.

How do you do a eCTD submission?

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).

When did eCTD become mandatory?

Is the eCTD Format Mandatory? One question you may have is whether or not the eCTD format is mandatory….

Submission Type Compliance Date
NDAs, ANDAs, BLAs May 5, 2017
Commercial INDs, Master Files May 5, 2018

What are the benefits of eCTD?

Advantages of the eCTD Structure Local affiliates can review updates in real-time. FDA reviewers can review faster and more efficiently, shortening time to approval. Handling, managing, and archiving trial and document-essential information is less time-consuming. Documents are easily accessible via search and tracking.

How many modules are in an IND?

A CTD has five modules: region-specific information (Module 1), summary documents (Module 2), quality-related (CMC) information (Module 3), nonclinical study reports (Module 4), and clinical study reports (Module 5). Historically, submissions to the FDA have been made in paper format.