Clarifying Health Canada’s Public Release of Clinical Information Draft Guidance – Part II
Last week we shared Part I of our three-part series on the questions and clarifications we submitted to Health Canada regarding their draft guidance on the Public Release of Clinical Information. Many thanks to everyone who commented with their insight. Following is Part II. Please leave your comments below to keep the conversation going.
Health Canada's Public Release of Clinical Information: Our Questions & Clarifications - Part II
Question #3: Line 378 specified that the final decision on what clinical information is publicly released resides with Health Canada. Does Health Canada then take the role of data controller? Who holds the accountability for patient privacy if compromised if there is a differing opinion between the sponsor and Health Canada? How does this final decision fit with company intellectual property considerations?
Question #4: Line 380 states that with appropriate certification, the manufacturer may submit to Health Canada final redacted documents that were previously accepted by the European Medicines Agency (EMA). If redaction was the method used for these EMA submissions, would this be accepted as is by Health Canada?
Question #5: Line 481 states Health Canada favors methods that retain analytical value. Is redaction a method that would be accepted? Would there be an exception process if this was the selected method by the sponsor?
Synchrogenix’s experts and thought leaders have a pulse on the future impact of decisions made today, which is why we offer comments on global draft guidances on behalf of life science companies worldwide.
What do you think? Were any of your comments similar or do you have insight into our questions? Please leave a comment below.
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