New FDA Guidance on Electronic Common Technical Document Submissions

November 3, 2005
Laura Bush

Laura Bush is a former managing editor of Pharmaceutical Technology and Editor-in-Chief of BioPharm International.

New FDA Guidance on Electronic Common Technical Document Submissions

On Nov. 28, the US Food and Drug Administration released a new guidance covering the content of electronic common technical document (eCTD) submissions. The new Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, updates the August 2003 draft guidance on the same topic.

The new guidance provides more specificity than earlier guidances regarding the organization of electronic submissions, and it harmonizes the organization and formatting of multiple submission types. The International Conference on Harmonization developed the CTD and the eCTD for marketing approval applications (ANDAs, BLAs, NDAs), but according to the new guidance, they can apply to other submission types such as INDs and master files. More details regarding the ICH eCTD can be found in the ICH guidance document M2 eCTD:  Electronic Common Technical Document Specification.  

The new FDA guidance is available at:

http://www.fda.gov/cder/guidance/6766fnl.htm