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Friday, April 23, 2010

Validation of eCTD Tools

BayBiotech.NET
Electronic Common Technical Document (eCTD) is an ICH standard adopted by FDA as a member of ICH, together with other member regions, Europe & Japan to facilitate electronic submissions to the agency. Harmonization of guidelines has been done to achieve global consistency in order to facilitate globalization of the drug discovery efforts. As of 2008, eCTD standard is the only acceptable format for new electronic submissions to the agency with an exceptions for submissions that are already under review. As the agency is working to standardize the eCTD process, it is encouraging the Industry to begin working on establishing a system for eCTD submissions. It is advisable to either use an in-house developed or commercially purchased e-CTD tool. In order to validate your eCTD tool, it will be important to pay attention to the following major issues identified by the agency regarding the eCTD submissions:

1. Lack of 356h, 1571, or 2252 forms in a submission.

2. Lack of .pdf Fillable Forms in a submission.

3. Usually more than one form in a submission is identified.

4. Mismatched, incorrect or missing application numbers.

6. Most of the eCTD submitted as eNDA.

7. More than one sequence included in one gateway submission.

8. One submission applied to more than one application.

9. Single file submission – Usually a single PDF file.

A validation plan to check for the abovementioned issues will help reduce the review time of a submission at the agency and will not cause a delay or return of your submission.

If you would like to read more on the eCTD submission, follow the link:
Electronic Regulatory Submission and Review (ERSR)

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