What are Health Canada’s current activities that relate to Product Vigilance (PV) and Risk Management?
Health Canada currently engages in risk management by reviewing: • Applications for the conduct of clinical trials in Canada to ensure that the rights of the participants are respected and that potential risks are mitigated; • Adverse drug reactions that happen during clinical trials in Canada; • Data submitted to Health Canada in drug submissions, including product information (labels, product monographs, package leaflets) to determine if the information requires specific risk management measures; • Adverse reaction reports and published scientific and medical literature to identify new risks; and • Periodic safety update reports, which are a tool for companies to conduct systematic analyses of safety data and systematically document their vigilance activities and interactions with federal regulatory agencies on a regular basis. Health Canada also: • Works with drug manufacturers and health professionals to develop risk management tools and select risk mitigation strategies; and • Ove
