The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > 2020 > 2 > FDA Finalizes eCTD Guidance, Consults on eCTD v4.0 Technical Documents

FDA Finalizes eCTD Guidance, Consults on eCTD v4.0 Technical Documents

Posted 21 February 2020 | By Michael Mezher 

FDA Finalizes eCTD Guidance, Consults on eCTD v4.0 Technical Documents

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.
 
FDA, Federal Register Notice

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe