Last week Health Canada released a whitepaper outlining a proposed change to the availability of clinical information in drug submissions and medical device applications. Currently, this information is considered confidential business information. The agency proposes that once a final decision is reached on a drug submission, this information would be made public. This is in line with how the European Medicines Agency and the United States Food and Drug Administration Currently operate.
Health Canada hopes that by making this information public it will provide the following benefits:
Benefits for patients and health care providers:
Benefits for clinical trial participants:
Benefits for medical research:
Canadians are welcomed to provide feedback by May 26, 2017. The full whitepaper is available here.