Health Canada, Canada’s medical device market regulator, has begun accepting some clinical trial-related information from sponsors via electronic submissions.
According to a notice from Health Canada, sponsors may now utilize the regulator’s recently developed electronic Common Technical Document (eCTD) format to file certain clinical trial regulatory activities. The eCTD format was made available following a Health Canada pilot period that concluded in August 2019.
Using eCTD for clinical trial regulatory activity submissions is currently optional, but once a sponsor has made a filing to Health Canada using the eCTD format, that sponsor must provide all additional data pertaining to the same protocol via eCTD.
Which clinical trial regulatory activities may be filed using eCTD?
Health Canada identifies the following clinical trial regulatory activities as eligible for eCTD submissions:
- Pre-clinical trial application consultation meetings (PRE-CTA);
- Clinical trial applications (CTAs) using either seven-day administrative or 30-day default performance standards;
- CTA notifications (CTA-N);
- Any responses and post-clearance data pertaining to regulatory activities mentioned above.
Information not within the scope of the eCTD format include clinical trial site information (CTSI), development safety update reports (DSUR) and certain information involving the Therapeutic Products Directorate and Biologics and Genetic Therapies Directorate.
Medical device clinical study sponsors targeting the Canadian market should refer to Health Canada’s guidance on using the eCTD filing format.