Health Canada publishes new amendments to the Food and Drug Regulations and Medical Devices Regulations allowing for public release of clinical information in regulatory submissions
On March 20, 2019, new amendments to both the Food and Drug Regulations (the Regulations) and the Medical Devices Regulations regarding the disclosure of clinical data were published in the Canada Gazette. These changes follow from the May 2017 release of Health Canada’s white paper – Public Release of Clinical Information in Drug Submissions and Medical Device Applications (which we have previously reported on here and here), and confirm Health Canada’s decision to…