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Electronic common technical document
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to transfer regulatory information to regulatory agencies. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).
Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, and version 3.0 was finalized on October 8 of the same year. As of August 2016[update], the most current version is 3.2.2, released on July 16, 2008.
A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 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.
On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs).
Health Canada was a sponsor and an early adopter of the eCTD workflow, especially for its Health Products and Food Branch regulator, but as of April 2015 had not yet fully automated it.
The E.U. and its European Medicines Agency (EMA) began accepting eCTD submissions in 2003. 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." The EMA verified on that date that it would no longer accept "human and veterinary centralised procedure applications" and that all electronic application forms would have to be eCTD by January 2016.
In November 2017, China Food and Drug Administration (CFDA) publishes draft eCTD structure for drug registration for public consultations. This is a big transition for China to move from paper submission to eCTD submissions.
The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has been eCTD compliant at least since December 2017.
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Electronic common technical document
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to transfer regulatory information to regulatory agencies. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).
Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, and version 3.0 was finalized on October 8 of the same year. As of August 2016[update], the most current version is 3.2.2, released on July 16, 2008.
A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 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.
On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs).
Health Canada was a sponsor and an early adopter of the eCTD workflow, especially for its Health Products and Food Branch regulator, but as of April 2015 had not yet fully automated it.
The E.U. and its European Medicines Agency (EMA) began accepting eCTD submissions in 2003. 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." The EMA verified on that date that it would no longer accept "human and veterinary centralised procedure applications" and that all electronic application forms would have to be eCTD by January 2016.
In November 2017, China Food and Drug Administration (CFDA) publishes draft eCTD structure for drug registration for public consultations. This is a big transition for China to move from paper submission to eCTD submissions.
The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has been eCTD compliant at least since December 2017.