What is eCTD submission format?

What is eCTD submission format?

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.

How is eCTD submitted?

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.

What is Module 1 of an eCTD compliant submission?

The electronic Common Technical Document (eCTD) standard format is designed to harmonize submission of data and information by pharmaceutical companies to regulatory agencies. Module 1 describes the administrative and prescribing information, such as the product information and labeling required by local regulators.

What are eCTD modules?

eCTD submissions include 5 parts, termed modules, with each containing a specific type of information. 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.

How do I submit eCTD to FDA?

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 sequence?

An eCTD application may comprise a number of sequences. Submission or Sequence A single set of information and/or electronic documents supplied at one particular time by the applicant as a part of, or the complete, eCTD Application. In the context of eCTD, this is equivalent to a sequence.

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.

What is eCTD publishing tool?

docuBridge is an advanced electronic submission management and regulatory document management system for compiling, publishing, importing, and reviewing. As an eCTD publishing tool, it is also useful for other regulatory submission formats including (V)NeeS, HTML, PDF and paper.

Does FDA accept paper submissions?

Non-commercial IND submissions (including investigator-sponsored INDs and expanded access INDs) are exempt. After these deadlines, paper submissions or electronic submissions that are NOT in eCTD format will NOT be filed or received unless exempt from the requirement.

What is DTD in eCTD?

“The XML eCTD DTD (Document Type Definition) defines the overall structure of the submission.

What are the other 3 forms used for the submission of the FDA for a NDA?

NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy.

When did US FDA make eCTD mandatory?

Beginning May 5, 2018, submitters MUST use eCTD for commercial IND submissions. Non-commercial IND submissions (including investigator-sponsored INDs and expanded access INDs) are exempt.

What do you need to know about the eCTD format?

The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Reminder: Per eCTD Guidance, NDA, BLA, ANDA, and Commercial IND submissions must include a FDA fillable form (e.g. 356h, 1571, 2252).

When to submit DMF type LLL in ECTD format?

For a listing of Specifications, Supportive Files, and versions related to eCTD, please refer to eCTD Submission Standards (XLS – 57KB) or eCTD Submission Standards (PDF – 91KB). The FDA extended the compliance date for submitting DMF Type lll in eCTD format to May 5, 2020.

What does the eCTD stand for in FDA?

Electronic Common Technical Document (eCTD) The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER)…

When do NDAs need to be submitted in ECTD format?

May 5, 2017: New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), must be submitted using eCTD format. May 5, 2018: Commercial Investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.