FDA Releases Final Guidance (Revision 7) for Industry that Clarifies Which Submission Types Qualify for an Exemption or Waiver from eCTD Requirements

FDA Releases Final Guidance (Revision 7) for Industry that Clarifies Which Submission Types Qualify for an Exemption or Waiver from eCTD Requirements 

The U.S. Food and Drug Administration (FDA) has released a final guidance for industry, “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications: Guidance for Industry ( Revision 7)” after the draft version was released in July 2019. The final guidance specifies that all Type III drug master files (DMFs) will qualify for an exemption from submission in Electronic Common Technical Document (eCTD) format. This is in addition to the current exemption for noncommercial investigational new drugs (INDs).

Plus, FDA will grant long-term waivers from the requirement to submit DMFs to FDA in eCTD format for certain positron emission tomography (PET) drugs and certain Type II DMFs that only support PET drugs or noncommercial IND applications. In certain extraordinary circumstances, FDA may grant a short-term waiver from eCTD submission requirements. The guidance includes instructions on how to submit a waiver request.

The eCTD is the standard format for submitting applications, amendments, supplements and reports to CDER and CBER. Please visit this FDA webpage for more information on the eCTD requirement process and this webpage for more information on DMFs.