Health Canada finalizes regulations to provide public access to clinical information on drugs and medical devices

March 13, 2019 - Ottawa - Health Canada

Canadians want greater access to credible information that will enable them to make well-informed decisions about their health and that of their families. Health Canada recognizes that increasing access to clinical data on drugs and medical devices can have widespread benefits throughout the health care system and on the health outcomes of Canadians.

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 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. At launch, the portal will include clinical information on a small number of products, provided by volunteer companies in advance of the final regulations.

Following the coming into force of the regulations, Health Canada will post clinical information from drug submissions as the Department completes its review of each submission. 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. Health Canada will also make information about drugs and medical devices already on the market available upon request, and add this information to the portal.

Health Canada consulted extensively with academic researchers, health care professionals, patient groups and industry on this approach to determine what information should be shared and in what form.

As part of its Action Plan on Medical Devices launched in December 2018, Health Canada committed to providing more information to Canadians on medical devices. These regulations represent one key component of that plan.