FDA 开放 eCTD v4.0 及标准化数据样本提交验证流程

FDA would like to assist sponsors and applicants who have not previously submitted in eCTD v4.0. We offer a process to validate sample eCTD v4.0 submissions and standardized study datasets. You must have an NDA, IND, BLA, ANDA, or MF number and plan to submit an actual submission to the FDA within 12 months of your sample request. Sample submissions are not considered official submissions and are not reviewed by FDA reviewers at any time. 

When testing is complete, FDA will provide you with feedback, highlighting the errors found during the processing of the sample submission.

Sample Submission Validation Process

Follow these steps to submit a sample submission:

1. Request a Sample Application Number
2. Submit your sample
3. Resolve technical issues
4. Submission and study data support

1. Request a Sample Application Number

To initiate the process of submitting a sample submission, notify the electronic submissions staff at ESUB-Testing@fda.hhs.gov to request a Sample Application Number.

Include the following in your email:

1. Contact’s Name - this will be the main contact during the sample submission phase
2. Contact’s Company Name
3. Contact’s Phone Number
4. Contact’s Email Address
5. NDA, IND, BLA, ANDA, or MF number
6. Planned Date of Official Submission
7. Description of test requested, including application type:
   • eCTD v4.0 new application
   • eCTD v4.0 Forward Compatibility
   • CDISC/SDTM, CDISC/ADaM or CDISC/SEND dataset 

The information you provide in your email request for a Sample Application Number should also be provided in the cover letter of your sample submission.

Once you have submitted your request and your contact information, a representative from the electronic submissions staff will contact you and assign a Sample Application Number, along with additional instructions.

2. Submit your sample submission according to supported specifications

Samples should be submitted as a Test Submission via ESG NextGen. 

If you are testing an eCTD v4.0 submission:

• please review
  • the recommended contents of the v4.0 sample submission
  • the recommended contents of the v4.0 forward compatibility sample submission
  • the eCTD v4.0 Submission Standards
• your sample submission will be validated using the eCTD v4.0 tool. For information about the specifications, standards, and tool, see the eCTD v4.0 Submission Standards
• you can include standardized datasets
  • please review Submit a Standardized Data Sample for more information

When testing is complete, you will be provided with feedback, highlighting the errors found during the processing of the sample submission.

3. Resolve technical issues following FDA feedback

Sponsors and applicants should review FDA's comments and correct all eCTD and data issues identified before making an actual submission to FDA. If there is an explanation for a data issue, it should be documented in the study data reviewer’s guide. Do not resubmit any sample information after you have received results from FDA as it will not be further evaluated.

4. Submission Validation Support

The sample submission validation process is limited to sponsors and applicants who plan to submit electronic standardized regulatory submissions using eCTD v4.0 format. The validation of sample submissions does not involve scientific review of the content and is only intended to address conformance to FDA supported electronic submission and data standards.

Contact Information

For additional information, contact the electronic submissions staff at ESUB-Testing@fda.hhs.gov.

Your point of contact will be notified when the submission is received. Generally, feedback is provided within 30 days of receipt of the sample submission, except during periods of high volume.