Health Canada finalizes regulations to provide public access to clinical information on drugs and medical devices
Health Canada regulation on “public access to clinical information on drugs and medical devices” is finally going to be published on March 20,2019 as per their Press release dated 13 Mar 2019.
On March 20, 2019, Health Canada will publish final regulations that allow for the public release of clinical information on drugs and medical devices. Clinical information is the data that companies provide when requesting authorization of these products, and includes study reports and clinical trial results. These regulations are one of the key transparency measures introduced under Vanessa’s Law.
Clinical information will be made available to Canadians through Health Canada’s new Clinical Information Portal as of March 13, 2019.
Proactive disclosure for medical devices will start in 2021, to coincide with steps the European Union is taking to increase the transparency of clinical information for medical devices, and to reduce the burden on stakeholders by aligning approaches”
Press release: www.canada.ca/en/health-canada/news/2019/03/…
Link to Health Canada’s new portal: clinical-information.canada.ca/search/ci-rc