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

OTTAWA, March 13, 2019 /CNW/ - 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.

Quotes

"The clinical information in drug and medical device submissions is a tremendous resource that researchers can tap into and use to benefit the health and safety of Canadians. I look forward to the new insights that will come from this rich source of open data."

The Honourable Ginette Petitpas Taylor
Minister of Health

Quick Facts

• The Health Canada Clinical Information Portal is an online tool to access clinical information about drugs and medical devices. It will allow site visitors to search for published material using key product identifiers and to request unpublished material.
• Health Canada will consult manufacturers to ensure that confidential and personal information is removed before the Department releases any information.
• Health Canada aims to release information about drugs within 120 days of completing the review of a drug submission.

Associated Links

Public Release of Clinical Information Guidance Document   
Public Release of Clinical Information Canada Gazette, Part I   
Request a copy of the regulations (Note: The regulations will be published in Canada Gazette, Part II, on March 20, 2019.)
Canada Gazette publications
Health Canada's Action Plan on Medical Devices
Report a Health and Safety Concern
New Safety and Effectiveness Reviews
The Drug and Health Product Register
MedEffect Canada
Summary safety reviews
Drug product database

SOURCE Health Canada

Thierry Bélair, Office of Ginette Petitpas Taylor, Minister of Health, 613-957-0200; Media Relations, Health Canada, 613-957-2983, [email protected]; Public Inquiries: 613-957-2991, 1-866-225-0709