Public release of clinical information
From Health Canada
See next steps for information on further consultations.
We are working to make clinical information about the safety and efficacy of drugs and medical devices available to the public. Information that Health Canada currently treats as confidential would be made publicly available following a final regulatory decision.
Clinical information is data about the safety and efficacy of drugs or medical devices used in humans. Companies that make drugs or medical devices send this information to Health Canada to help us review products for sale in Canada.
Clinical information is submitted in clinical study reports. These reports include information on the design and results of clinical trials. A submission for a single product can include tens of thousands of pages of clinical information, including individual patient data.
Public access to clinical information will allow independent analysis that increases our understanding of the safety and efficacy of health products. This can improve patient care in Canada by:
- helping patients and healthcare providers make better decisions about using drugs or medical devices
- reducing research participant exposure to harm during duplicative studies
- using analysis of existing data to advance new research
We are consulting with:
- health researchers
- health professionals
- patient groups
- pharmaceutical industries
- medical device industries
Health Canada invites stakeholder's comments on how it carries out this proposal, including the:
- regulatory approach
- scope of clinical information that would be publicly available following a final regulatory decision
- clinical information that has ongoing commercial value and could be withheld from public release.
When and where
Written comments were provided on-line for 75 days from March 10 to May 26, 2017.
How to participate
Please read our white paper and and the What We Heard report.
If you have questions or comments, please email us.
1. Technical consultations on clinical information release
Health Canada is in the process of initiating a new round of expert and stakeholder consultations, focused on technical issues pertaining to operationalization of the public release of clinical information. We will work with experts who responded to a public call letter soliciting individuals with expertise to provide advice on:
- data protection and privacy law
- health data science and statistics
- open data and end-user experience
- clinical trial reporting, medical writing
- anonymizing and de-identification methods
- regulatory affairs and common technical document (CTD) structure
Expert advice in these areas will contribute to our analyses and recommendations, which will be presented for feedback from stakeholders, including drug and medical device manufacturers, health care providers, academic researchers and patient groups. Information on these meetings will be published regularly on this site.
2. Public consultation on draft regulations
In the late fall of 2017, Health Canada intends to propose draft regulations to support public release of clinical information in drug submissions and medical device applications. There will be further public consultations after the draft regulations are published.
Office of Information Management
Resource Management and Operations Directorate
Health Products and Food Branch
Graham Spry Building
250 Lanark Avenue
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