The US Food and Drug Administration (FDA) on Friday finalized the seventh revision to its guidance on making regulatory submissions in electronic common technical document (eCTD) format to specify cases where an exemption or waiver from eCTD requirements is warranted.
The 17-page guidance finalizes a draft version released in July 2019 and replaces the previous final version from January 2019.
Within the guidance, FDA says it will exempt all Type III drug master files (DMFs) from eCTD requirements, in addition to noncommercial investigational new drugs (INDs).
The final guidance also clarifies that certain positron emission tomography (PET) drugs and Type II DMFs for PET drugs may qualify for a long-term waiver from eCTD requirements. Additionally, the final guidance explains the “unique and rare” circumstances in which the agency will grant short-term waivers from eCTD requirements, including events “beyond the control of the submitter,” such as natural disasters or malware attacks.
FDA also opened a public consultation on Friday for two eCTD technical documents, the eCTD v4.0 Technical Conformance Guidance and the FDA eCTD v4.0 Module 1 Implementation Package.
The eCTD Technical Conformance Guide is meant to provide drugmakers with “specification, recommendations, and general considerations” for filing eCTD v4.0-based submissions with the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) using either the International Council for Harmonisation or FDA implementation packages.
FDA says it is looking for comments to ensure the “accuracy, suitability, and appropriateness of these specifications for the submission of eCTD v4.0 submissions,” and notes that the documents are not meant for implementation at this time and that the agency will “only accept eCTD v3.2.2 submissions” until v4.0 is finalized.
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