USA – What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains

The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver.

As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applications. Type III DMF submissions in eCTD were previously not expected to take effect until 5 May 2020.

But FDA says, “Compliance with eCTD submission requirements can represent a significant burden to support use of their packaging products for pharmaceuticals when balanced against their business interest in supplying their products for this use…There is a possibility that this regulatory burden could result in firms ending their supply of these critical materials to the pharmaceutical industry, which could lead to drug supply interruptions and drug shortages.”

In addition, the burden of allowing non-eCTD submissions for Type III DMFs “is expected to be reasonably low,” the agency said in a Federal Register notice