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Regulatory Focus™ > News Articles > 2020 > 2 > Health Canada Begins Implementing eCTD for Clinical Trial Applications

Health Canada Begins Implementing eCTD for Clinical Trial Applications

Posted 19 February 2020 | By Michael Mezher 

Health Canada Begins Implementing eCTD for Clinical Trial Applications

Following a successful pilot that wrapped up in August, Health Canada says it will immediately begin accepting certain clinical trial submissions in electronic common technical document (eCTD) format.
 
In recent years, Health Canada has moved to increasingly accept or require eCTD format for various submissions, including new drug submissions (NDS), abbreviated new drug submissions (ANDS) and drug master files (DMFs).
 
Specifically, Health Canada says it will allow eCTD submissions for pre-clinical trial application consult meetings (Pre-CTA), clinical trial applications (CTAs), amendments (CTA-As) and notification (CTA-N), as well as responses and post-clearance data related to any of the aforementioned applications.
 
While sponsors are not required to use eCTD format for clinical trial activities, Health Canada says that “Once a sponsor files a regulatory activity in eCTD format, all additional information and subsequent regulatory transactions for the same dossier (protocol) must also be filed in eCTD format,” and notes that sponsors are not able to revert an eCTD dossier to non-eCTD electronic-only format.
 
Health Canada also says that certain clinical trial regulatory activities and transactions are “out-of-scope for filing in eCTD format,” including submitting clinical trial site information (CTSI), development safety update reports (DSURs), signal assessment related requests or fax-backs for the Biologics and Genetic Therapies Directorate.
 
Sponsors looking to submit clinical trial applications and related submissions using eCTD format are instructed to use the Common Electronic Submissions Gateway and follow Health Canada’s eCTD guidance.
 
Health Canada

 

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