Canada - Proposing amendments to the Food and Drug Regulations (Vanessa's Law) Department of Health has proposing amendment to the Food and Drug Regulations by introducing regulations that govern the issuance of Ministerial orders to reassess the benefits and harms of a drug, or conduct additional tests and studies. The amendment would also require therapeutic product authorization holders to provide the Department with the foreign risk communication(s) undertaken within the jurisdictions of specified foreign authorities. It would also repeal the requirement, under Division 8 of the Food and Drug Regulations, to provide clinical case reports. These regulations would support the coming into force of the new assessment and test and studies powers included in Vanessa's Law by establishing the rules needed to structure the exercise of those powers. They would further support post-market drug safety by creating new foreign incident reporting rules. Finally, the regulations would reduce unnecessary requirements by removing a NDS reporting obligation. Products covered : Prescription and Ethical Drug Products Proposed date of adoption : On the date the amendments are registered. Notification of registration will occur through publication in Canada Gazette, Part II, which is anticipated to be 12 months following publication in Canada Gazette, Part I. Proposed date of entry into force : The proposed amendments would come into force 6 months after the day on which they are published in Canada Gazette, Part II. Final date for comments : 6 July 2017 | 
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