Electronic Common Technical Document

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

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. 

BLA—Biologies License Application (eCTD and eBLA format) eCTD—Electronic Common Technical Document IDE—Investigational Device Exemption IND—Investigational New Drug Application (eCTD and eIND format)... 

For more information on submission of an ANDA in Electronic Common Technical Document (eCTD) format, please go to http //www.fda.gov/cder/ regulatory/ersr/ectd.htm. 

The current global initiative to harmonize electronic submission format and content requirements effectively creates one standard data package for drugs or biologies. Thus, the eNDA (electronic new drug application) or eBLA (electronic biologies license application) will eventually be replaced by the eCTD (electronic common technical document). 

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 Draft Guidance.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. 

The common technical document (CTD) (ICH M4) is now a requirement. The CTD is the agreed common format for the preparation of a well-structured application to the regulatory authorities and has had an impact on all organisations as database integration and electronic submissions become more common. 

Common Technical Document (CTD). The meeting discussed the implementation of both the paper and electronic versions of the CTD with particular relevance to biotech products and new chemical entities. 

Efficacy 12 topic headings 16 guidelines Safety 7 topic headings 10 guidelines Quality 7 topic headings 18 guidelines Medical Dictionary MedDRA Electronic Standards ESTRI Timing of Preclinical Studies Common Technical Document CTD... 

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. 

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