In this post, the Pharma in Brief team reports on two recent developments in the Quebec regulatory landscape related to the COVID-19 crisis. Adjustments to submission procedure for applications for listing of innovative drugs and blood products on formulary On April 6, 2020, Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) issued … Continue reading
On April 22, 2017, the Government of Canada published draft regulations Amending the Food and Drug Regulations (Vanessa’s Law) that provide details regarding the minister of health’s powers to require tests, assessments and studies of a drug post-market authorization. The draft regulations also set out additional reporting requirements for manufacturers based on the actions of … Continue reading
