Clarifications Concerning Health Canada’s Draft Guidance on the Public Release of Clinical Information – Part III
Over the past two weeks we have shared our questions and clarifications concerning Health Canada's draft guidance on the Public Release of Clinical Information. Following is Part III, which represents the conclusion of this series. Please click here to read Part I. Please click here to read Part II.
Clarifications Concerning Health Canada's Draft Guidance on the Public Release of Clinical Information
Question #6: Will sponsors going through this process for the first time have an additional first meeting with Health Canada to ask questions and/or to confirm scope as the European Medicines Agency (EMA) has with its pilot meeting?
Question #7: Has there been any discussions with the European Union to, in return, allow Health Canada submissions to be certified for EMA Policy 0070 publication?
Question #8: Are there expectations that Health Canada will process and publish any transparency submissions in 2018?
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.