Public release of clinical information
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.
We are currently involved in two streams of consultation:
- Public consultations on draft regulations for the public release of clinical information
- Technical consultations with stakeholders regarding the implementation of public release of clinical information
Public consultation on draft regulations
In December 2017, Health Canada proposed draft regulations to support public release of clinical information in drug submissions and medical device applications.
Following publication on December 9, 2017, in Canada Gazette I, draft regulations concerning the public release of clinical information were posted online for a 75-day public comment period (closing February 22, 2018).
Technical consultations on clinical information release
Health Canada has begun a new round of consultations, focused on technical issues pertaining to operationalization of the public release of clinical information. Through responses to our public call letter we compiled a roster of experts and have established a stakeholder reference group with expertise in:
- 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
This group is comprised of a balanced representation of interested stakeholders. Advice and recommendations from this group will focus on technical aspects of implementation of public release of clinical information, which will inform guidance for both producers and prospective users. Health Canada expects to meet with this group regularly from October 2017 until March 2018. Information on these meetings will be published regularly.
When and where
Feedback on the public consultation will be collected between December 9th, 2017 and February 22, 2017
Technical consultations with the stakeholder reference group will be on-going until March, 2018
How to participate
For further information on stakeholder engagement, both past and ongoing, you may also view a list of meetings for which documents are available on request.
- Mailing address
Office of Information Management
Resource Management and Operations Directorate
Health Products and Food Branch
Graham Spry Building
250 Lanark Avenue
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