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 is FDA eCTD?

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).

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.

How does the FDA define the official IND receipt date?

When FDA receives a submission, the submission is assigned a receipt date. This date may be used to determine important regulatory milestones. For example, the receipt date of an IND establishes FDA’s 30-day safety review cycle for the application.

What is eCTD compliance?

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 also simplifies the process of submission as all the Regulatory authorities use it as a standard format.

What is eCTD module?

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).

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 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 long does the FDA have to respond to IND submissions?

30 calendar days
The FDA is required to respond to an IND sponsor within 30 calendar days of receipt of a complete IND application. An IND goes into effect 30 days after the FDA received the SI may begin the study 30 days after FDA receives the IND application.

What is DTD in eCTD?

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

When did eCTD become mandatory?

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