Increased transparency benefits Canadians and the health care system
OTTAWA, Dec 8, 2017 /CNW/ - Health Canadais modernizing its approach to disclosing clinical information on drugs and medical devices to support advances in medical science and help improve patient care. Today, Health Canada published draft regulations in Canada
Health Canada uses clinical data when making regulatory decisions on drug and medical device submissions. These data provide comprehensive information on the safety and efficacy of these products. Increasing access to clinical data can have widespread benefits for patients and the health care system, for example:
In considering how best to make this information more broadly available, Health Canada sought public input on a discussion paper that was published online. It is also consulting expert stakeholders, including industry representatives, academic researchers and healthcare professionals on implementation of these proposed regulations.
The draft regulations are available for public comment for a 75-day period, beginning December 9.
"Greater access to clinical information can assist researchers and health professionals, contributing to improved patient safety and better health outcomes for Canadians."The Honourable Ginette Petitpas TaylorMinister of Health
Discussion Paper: Public Release of Clinical Information in Drug Submissions and Medical Device Applications
Guidance Document Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act
SOURCE Health Canada
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