On 6 November 2014, the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) received royal assent and amended the Food and Drugs Act to enable Health Canada to effectively and efficiently regulate the approval and safety of drugs for Canadians based on a lifecycle approach.

This proposal would amend 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.