19.05.2015

FDA releases final guidance for certain human pharmaceutical product applications; mandates eCTD submissions

Stars and Stripes

The Food and Drug Administration (FDA) has finally released the final Guidance for Industry "Providing Regulatory Submissions in Electronic Format —Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications", Revision 3, dated 15 May 2015 (download link)

Scope of the guidance:

This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for the electronic format of the content submitted in drug applications for human medicinal products(1) including NDAs, ANDAs, certain BLAs and certain INDs submitted to CDER or CBER.

  • Why "certain INDs"? - The guidance is not applicable to noncommercial INDs and to INDs that are regulated by CBER as biological products under section 351 of the PHS Act and that also require the submission of an IND prior to submission of a BLA.
  • Why "certain" BLAs? - As for INDs the guidance is not applicable for BLAs for products being regulated by CBER as biological products under section 351 of the PHS Act. It is furthermore not applicable to submissions for blood and blood components, including source plasma.

Timetable:

Under section 745A(a) of the FD&C Act, at least 24 months after the issuance of the present final guidance in which the FDA has specified the eCTD format (by reference) for the submission types mentioned under the scope above, such content must be submitted in eCTD format to the FDA:

  1. NDAs, ANDAs, BLAs and Master files must be submitted in eCTD format beginning May 15, 2017
  2. IND submissions must be submitted in eCTD format one year later, beginning May 15, 2018

(1) Background: The FDA decided that it would not be feasible to describe and implement the electronic format applicable for all submissions covered by section 745(A) of the FDA&C Act in a single guidance document. Instead the requirements will be implemented by a set of individual guidance documents that each will cover specific submissions / product types. The corresponding "umbrella" guidance "Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act" was finally released in December 2014 by the FDA

Further guidance documents released by FDA under these provisions include (but are not limited to):

[Source: FDA]

 

 

 

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