FDA releases guidance on electronic drug applications

Dive Brief:

  • The Food and Drug Administration is ironing out new rules for how drug companies can electronically submit medications for approval, and on Dec. 28 unveiled a draft of what they have planned so far.
  • The draft largely focused on manufacturing establishment information (MEI) — things like a production facility's address, what it's manufacturing, how to reach the person in charge of scheduling inspections, as well as a unique facility identifier, which the agency uses to keep track manufacturing plants.
  • The FDA is requiring companies to electronically submit MEI for each facility, but all in a single list. Companies must provide those lists for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and any other supplemental materials.

Dive Insight:

There are some noteworthy specifics to the agency's guidance.

For instance, the electronic submission rules don't apply to noncommercial investigational new drug (IND) applications. They do, however, apply to drug master files, which often contain non-public information about a medication or the methods used to make it.

Once the final version of the guidance gains approval, drugmakers will have 24 months before the new rules become mandatory.

The agency noted several reasons for the push toward electronic MEI submissions. The primary one was the convenience of having all the information on a single file versus non-electronic applications, where it can be scattered.

Additionally, the transition would speed up the review process for manufacturing facilities and help cut out "potentially outdated and erroneous information that, lacking clear information in the submission, might otherwise be retrieved from another Agency," the FDA said.

The agency will accept recommendations about the draft guidance for up to 60 days, a deadline that should come in late February.

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Filed Under: Regulatory / Compliance Manufacturing
Top image credit: nokhoog_buchachon