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New regulations governing powers to require assessments, tests and studies and notification of foreign incidents

On April 20, 2018, the sections of Vanessa’s Law that grant powers to the Minister to require assessments, tests and studies, and to create appropriate regulations came into force.  The accompanying Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) came into force on April 23, 2018 other than the provision relating to foreign risk reporting requirements which will come into force on October 23, 2018.

The amendments to the Regulations, among other matters:

  • Eliminate the requirement for filing clinical case reports in a filed submission or supplement, unless requested by the Minister, in order to alleviate administrative burden.