Posted by Michael Wonder on 12 Oct 2019
Canada's decision to make public more clinical trial data puts pressure on FDA
11 October 2019 - Last March, Canada's department of health changed the way it handles the huge amount of data that companies submit when seeking approval for a new drug, biological treatment, or medical device — or a new use for an existing one.
For the first time, Health Canada is making large chunks of this information publicly available after it approves or rejects applications.
Within 120 days of a decision, Health Canada will post clinical study reports on a new government online portal, starting with drugs that contain novel active ingredients and adding devices and other drugs over a four-year phase-in period.
