Electronic common technical document

The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information.

An additional Draft Implementation Guide was released in February 2015[5] The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the guidance and any queries or clarifications that might be necessary.

[6] On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document[7] requiring certain submissions in electronic (eCTD) format within 24 months.

[10] In February 2015, the "EMA announced it would no longer accept paper application forms for products applying to the centralized procedure beginning 1 July 2015.

[14] The Electronic Common Technical Document Specification, the main ICH standard, largely determines the structure of an eCTD submission.

In the United States, the Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications.

The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver.