FDA's New Roadmap for Electronic Format Submission Offers Vision but Few Details

Posted 05 February 2014 | By Alexander Gaffney, RAC 

New draft guidance released this week by the US Food and Drug Administration (FDA) aims to explain a roadmap for how pharmaceutical and biopharmaceutical manufacturers will eventually need to submit marketing applications electronically as required by federal law.


In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed into law, and with it a provision mandating that all applications submitted under Section 505(b)/(i)/(j) or 351(a)/(k)-that is, any new drug, investigational drug, generic drug, biologic drug or biosimilar drug-would need to be submitted electronically in a format specified by FDA.

The requirement is set to begin at least 24 months after FDA issues a final guidance indicating which electronic submission format it wishes to use, but FDA has evidently run into something of a problem: There's a lot of information it still needs to work on clarifying

"The Agency has concluded that it is not feasible to describe and implement the electronic format(s) that would apply to all the submissions covered by section 745A(a) in one guidance document," it said in a draft guidance released on 5 February 2014.

As a result, Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A(a) of the  Federal Food, Drug, and Cosmetic Act  is intended to act as a road map illustrating how FDA plans to implement the requirements of section 745A(a) of the Federal Food, Drug and Cosmetic Act.

Its map covers three topics, FDA said:

  1. the submission types that must be submitted electronically
  2. exemptions from and waivers of the electronic submission requirements
  3. the timetable and process for implementing the requirements


As noted earlier, all New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) must be submitted electronically. In addition, all amendments, supplements and reports to those submission types "must be submitted electronically even if the original submission was submitted to FDA prior to implementation of the electronic submission requirements," FDA wrote.

However, only "certain" Biologic Licensing Applications (BLAs) and Investigational New Drug Applications (INDs) need to be submitted. Which ones? You'll have to wait and see, FDA said. "Exemptions, if available, will be discussed in individual guidances," it wrote.

Regardless, submissions not made electronically when they are required to have been will not be accepted by FDA, the regulator said.

Future changes to the format, once it is implemented, will allow industry between two weeks and 24 months to implement the changes, depending on the scope of the changes. Major changes, such as a new format, will allow industry 24 months to implement the changes. Even more substantial changes may allow for 36 months, while routine updates will likely allow for 12-month implementations. Minor corrections will take just two weeks to implement, FDA said.

The guidance is also something of an anomaly. While most guidance documents are just formal agency recommendations on how to expedite approvals, FDA notes that this guidance contains some "binding provisions" that make it unlike most normal guidance documents.


Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A(a) of the  Federal Food, Drug, and Cosmetic Act

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