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

Regulatory NewsRegulatory News | 16 July 2019 |  By 

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.


And for a long-term waiver from eCTD requirements, FDA singles out certain positron emission tomography (PET) drug products and certain Type II DMFs supporting PET drugs or noncommercial submissions or applications.

For PET drugs, which are used in evaluating patients with coronary artery disease and in certain neurologic disorders, “FDA believes that the requirement to submit applications in eCTD format could result in a significant burden on certain PET drug producers and may lead to reduced availability of these innovative and lifesaving diagnostic drugs.” The guidance sets forth certain conditions by which a PET drug producer can request a waiver from the eCTD requirements.

As far as the Type II DMFs, FDA notes how in some cases, a Type II DMF submission may come from an academic sponsor so compliance with eCTD submission requirements can represent "a significant burden" and may impede research.

“FDA proposes to waive the requirement to comply with eCTD submission requirements for certain Type II DMF submissions from an academic institution, government (State or Federal), or a non-profit research organization that are solely supporting a noncommercial application,” the agency said.

In addition, the revised guidance, which is the seventh revision of the document, outlines certain circumstances under which FDA may determine that a short-term waiver from eCTD submission requirements could be granted.

Revised Guidance

Updated on 7/16/19 with a link to the revised guidance (above).


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