FDA issues revised draft guidance for providing Regulatory Submission in e-CTD format

FDA Draft Guidance: Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications adn Related Submissions Using eCTD SpecificationsOn July 25, 2014 FDA issued revised draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.”   This revised draft guidance was previously issued in January 2013, which will supersede the guidance for industry titled “Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” issued in June 2008 when it is finalized.

This guidance outlines a variety of regulatory reforms, specifications and development programs on how sponsors and applicants must organize the content of all submission types (505(b) (new drug), 505(i) (clinical trial), 505(j) (generic drug), 351(a) (biologic) and 351(k) (biosimilar)) submitted to the Agency electronically.

The notable changes compared to the previous draft guidance are.

  • The new guidance describes certain drug master files, advertising and promotional labeling materials will fall within the scope of section 745(a) of FD&C Act.
  • The new mention describes the mandatory use of FDA Electronic Submissions Gateway (ESG)
  • In addition, the new guidance describes that all eCTD submissions filed to FDA should use the fillable forms and also have specific file format and software version

Comments on this guidance are open to FDA until 23 September 2014. The eCTD submission requirements will go into effect 24 months after the availability of the final guidance.

Importantly throughout this guidance, the FDA utilizes the words “must or required” to indicate that this guidance “document is not subject to the usual restrictions in FDA’s good guidance practice (GGP) regulations” as “Congress granted explicit authorization to FDA to implement the statutory electronic submission requirements.” Once this guidance is in effect, any submission not submitted electronically or with the specific format outlined in this guidance will not be filed (“unless exempted from the electronic submission requirement”).

The complete draft guidance can be accessed here:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf

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