ECTD specification

Electronic Common Technical Document (eCTD) specifications. www.ich.org... 

Essentially, the eCTD is a transport format for facilitating electronic submissions. The eCTD serves as an interface for industry-to-agency transfer of regulatory information while at the same time, taking into consideration the facilitation of the creation, review, life cycle management, and archival of the electronic submission. The eCTD specification lists the criteria that will make an electronic submission technically valid. The eCTD represents a major advance in the submission of information to support an NDA. In the future, companies may be able to send their submissions to several regulatory authorities simultaneously with a single stroke of a computer key. 

U.S. Department of Health and Human Services (2006), Guidance for industry Providing regulatory submissions in electronic format—Human pharmaceutical product applications and related submissions using the eCTD specifications, Food and Drug Administration, Rockville, MD. 

Drug Master File (DMF). Refer to the Guidance for Industry Providing Regulatory Submissions in Electronic Format-Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications for information on the submission of electronic DMFs. 

Electronic Common Technical Document Specification. ICH M2EWG. Draft Guidance. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH eCTD Specification V 2.0. February 12, 2002. 

Analytical scientists have welcomed ICH M4 Q—Common Technical Documentation (CTD) as a globally accepted format to provide information and scientific data in drug application submission. Recently, FDA and EU regulatory agencies have encouraged and allowed applicants for the electronic submission of the common technical documentations using ICH eCTD specification. 

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

By necessity, that effort was 6 months behind the harmonized format. It is difficult to describe the specifications for electronic transmission if you do not know what you are transmitting. As a result, the eCTD Working Group had to wait for the CTD to be finalized before they could complete their work. The ICH Steering Committee adopted the final version of the eCTD at the meetings held in Washington, DC, in September 2002. 

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