Government of Canada Seeks Input
Health Canada invites comments on proposed changes to permit the release of clinical information related to drugs and medical devices.
The following information is excerpted from Health Canada's website:
Why
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
Who
We are looking for comments from:
- health researchers
- health professionals
- patient groups
- pharmaceutical industries
- medical device industries
What
Health Canada is looking for 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 can be provided on-line for 75 days from March 10 to May 26, 2017.
In-person meetings with stakeholder groups and technical experts will be scheduled from spring to fall of 2017.
How to participate
Please read our white paper and submit your comments using our comment form.
If you have questions or comments on this document, please
email us.
All comments must be received by May 26, 2017.
We want to encourage people to write in saying they want the government to support the UK based AllTrials campaign:
The Government of Canada's white paper can be read here.
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