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 a notice to drug manufacturers and blood system product manufacturers describing temporary measures implemented recently to avoid processing backlogs for applications for listing on Quebec’s formulary during the COVID-19 crisis. As of March 30, 2020, manufacturers of innovative drugs or blood products can submit their registration applications to INESSS electronically through the Ministry of Health and Social Services’ secure ShareFile platform. This change does not apply to the submission procedure for manufacturers of generic drugs or natural health products. Moreover, no pre-submission or post-submission meetings shall take place in person until further notice. Teleconference meetings are allowed.
New clinical trial for potential COVID-19 treatment
On March 23, 2020, the Quebec government, with partners in industry and academia, launched a clinical trial called COLCORONA, aiming to assess a short-term treatment’s ability to reduce the rate of death and lung complications related to COVID-19. Researchers for this randomized, double-blind, placebo-controlled study seek the enrollment of 6,000 participants aged 40 or over, who have been diagnosed with COVID-19 and have not been hospitalized.
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For more information on the legal implications of COVID-19, please consult our COVID-19 Hub. As a full service global firm with offices across Canada, Norton Rose Fulbright is closely monitoring this evolving situation over a number of practice areas including employment and labour, risk advisory, banking and finance, corporate, M&A and securities, and dispute resolution and litigation, and across a variety of industries including energy, infrastructure, mining and, financial institutions, life sciences and healthcare, technology and innovation, and transport.