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Electronic Submissions Update: End of FDA Paper Submissions Looms and What It Means
Under section 745A(a) of the FD&C Act, no earlier than 24 months after FDA issued the final guidance on December 2014, “
The guidance documents triggering the above cited effective dates are published. Guidance describing the requirements were published in two parts: the first specifies overall submission standards, and the second describes standards specific to clinical and nonclinical study data:
The guidance describes additional requirements, including:
The FDA compiled the list of specifications and supportive files for eCTD submissions into a single document, eCTD Submission Standards. The document contains the accepted file formats, supported versions, dates that support begins/ends, dates the requirement begins/ends and hyperlinks to the regulatory references. The eCTD Submission Standards are periodically updated on the FDA Electronic Common Technical Document (eCTD) web page.
The FDA compiled a set of standards into a single location for sponsors to identify all data exchange standards, file formats and terminology standards supported in the FDA Data Standards Catalog. The catalog contains accepted file formats, supported versions, dates that support begins/ends, dates the requirement begins/ends, and hyperlinks to the regulatory references. The catalog is periodically updated on the FDA Electronic Common Technical Document (eCTD) web page and on the FDA Study Data Standards Resources web page.
Enforcement: Technical Validation.
For standardized study data requirements, at the time of submission, the FDA will determine if the clinical and non-clinical study(ies) within the submission must comply with the standardized study standards based on the start date. In order to perform the assessment, the FDA added validation for study data to the technical validation criteria performed during the technical validation process. Therefore, the FDA will reject a submission for failure of technical validation criteria.
A Technical Rejection Criteria for Study Data document is published on the FDA Electronic Common Technical Document (eCTD) web page and on the FDA Study Data Standards Resources web page.
In both cases, a rejection notice in the form of a third acknowledgement is sent via the ESG, and it will specify an error number. The sponsor should refer to the technical rejection criteria for study data document to obtain the details of the error and the required corrective action. The technical contact listed in the application will NOT be notified. Technical validation usually occurs quickly, but the FDA is allowed 3 days; therefore, the sponsor should monitor their ESG account until the third acknowledgement arrives.
There are two additional technical validation criteria which do not result in technical rejection:
In the instance described above, since the submission was not uploaded onto the FDA server (i.e., not received), a receipt date was not established. When the submission is corrected, either the same sequence number, or a new sequence number may be used.
Camargo has longstanding experience with the FDA, including involvement with more than 1100 FDA meetings. For assistance with achieving the new FDA electronic filing standards, contact us.
Author: Annette Arlinghaus, Camargo Associate Director of Submissions
Granularity Document: Annex to M4: Organization of the CTD (October 2005)
The following documents are periodically updated on the FDA web pages specified below:
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