Author: Pinky Mazumder
On May 7, 2018 Health Canada published a notice announcing the start of a 90-day consultation on the submission of Master Files in eCTD format. Although acceptance of Master Files in eCTD format began earlier in 2015, it will be mandatory to format Master Files in the eCTD structure when making submissions to Health Canada starting January 1, 2019. This new regulatory requirement is part of Health Canada’s transition to an electronic only environment and to align with the requirement to submit regulatory transactions through the Common Electronic Submissions Gateway as of January 2017.
The following are required/recommended in eCTD format when preparing Master Files for Health Canada:
- a pre-technical meeting with the regulatory authority when filing a Type II (Container Closure System) and Type III (Excipient) Master File or a Master Files for the first time in eCTD;
- a sample of the Master File in eCTD
Once the sample is approved and the pre-technical meeting has been completed, the sponsor must then request a Dossier Identifier via email to hc.ereview.sc@canada.ca. The email is to be accompanied with a completed application form. Additional subsequent transactions and information following the filing of a Master File is also to be submitted in eCTD format. Master File transactions are to be submitted through the Common Electronic Submissions Gateway.
Health Canada is soliciting feedback on these requirements as part of the 90 day consultation period commencing May 7, 2018. The purpose of the consultation is to receive feedback from the stakeholders on the proposed mandatory date of January 1, 2019. Interested parties are to submit their input via email to hc.erview.sc@canada.ca by August 10, 2018
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