Hi Nomi!
MedTech Canada has been actively engaged with Health Canada on this file - in fact, there was a session on it this past Monday at the MedTech Canada conference. What I can tell you from what I understand of the current situation (with the caveat that I have NOT been through the process myself):
- the dates for proactive release have been pushed back to Mar. 2022 and Mar. 2023
- awareness is decent amongst those of us active in the associations, etc., but unless one has some source for this type of information or is vigilant in checking for Health Canada's release of documents, this may well have escaped the notice of some.
- only a few manufacturers have so far gone through the experience, Health Canada has indicated that there have not been many requests for retroactive data come through at this point
- it is well worth communicating with your clinical folks on how clinical evidence should be presented. Health Canada has indicated that they will *not* redact information from the "clinical section" of the submission just because it is not truly clinical. It must meet the definition of Confidential Business Information that is found in the Food and Drugs Act, and that is a very narrow definition. If you use a CER in your submissions verbatim, you may well be exposing information that you would rather not.
- I can't really speak to the CESG, unfortunately - I have not used it personally at this point. From conversations with colleagues, I don't believe there have been too many difficulties. From what we understand, when it comes to its use in submissions per se, it binds you to a specific format and the use of the CESG for all interactions on that licence going forward, so we have been a little bit relunctant to take that plunge at this point.
Hope that is at least a little bit helpful.
Best regards,
Greg
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Gregory LeBlanc RAC
Director, Regulatory Affairs and Quality Systems
Stouffville ON
Canada
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Original Message:
Sent: 09-Dec-2020 20:00
From: Nomi Steen
Subject: Health Canada - Public Release of Clinical Information (PRCI)
Hi all,
I'm interested in how medical device manufacturers are planning for Health Canada's Public Release of Clinical Information:
https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/profile-public-release-clinical-information-guidance/document.html#s3.3
From what I can tell, starting in 2021 for Class IV devices and 2022 for Class III devices, clinical data used to support license applications & amendments will be proactively posted to Health Canada's Clinical Information database following agreement between the manufacturer and Health Canada on specific Confidential Business Information & Personal Information redactions.
I'm curious about the following:
- Is there is broad awareness of this guidance for medical device manufacturers?
- Since the public release of clinical information has been available retroactively upon request since 2019, has anyone has gone through this process for a medical device and willing to share their experience?
- Is anyone is planning on changing the clinical information provided in a medical device license amendment as a result of this guidance (ex: CER)?
- Since the exchange of documents will occur through the Common Electronic Submissions Gateway (CESG), can anyone share their experience using this system?
Any insight would be appreciated!
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Nomi Steen
Regulatory Affairs
Elkton MD
United States
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