Questions Regarding the Public Release of Clinical Information Draft Guidance – Part I
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. Nirpal Virdee, Synchrogenix's Director of Client Services and Technology, recently submitted feedback to Health Canada regarding their draft guidance on the Public Release of Clinical Information in support of the many pharmaceutical companies whom we support with their global transparency commitments.
In this 3-part series we will share all of our questions and clarifications regarding Health Canada's draft guidance on the Public Release of Clinical Information.
Questions and Clarifications - Part I of III - draft guidance on the Public Release of Clinical Information
- We gather that as well as proactive submissions, there is the option for the public to request past submissions through the Health Canada portal. In line 308, will the time limit of 60 days from initiation of the process apply to retrospective request? How far back can the request go for older submission? There is a concern that very old submissions will be paper based with poor scanning quality and the time needed for very large submissions to digitize could be challenging within the specified time period. Would the timeline be negotiable in these types of scenarios? For submissions that are electronic and retrospective, will the same time period be applied as it does for prospective submissions?
- Line 344 specified that the public can make a request with pre-defined data. Does the public need to know every data element in the list to have the request supported by Health Canada or if only partial data is known/provided, will that also be a valid request? Who determines huge public interest? Is that determined by Health Canada when prioritizing requests?
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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