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A Success But Room For Improvement: Canada’s Conditional Approval Pathway

 
• By Neena Brizmohun

Ninety-two approvals, seven revocations and myriad standard-of-care treatments are all discussed in a first-of-its kind study examining the data and nuances of oncology submissions processed under Health Canada’s 26-year-old notice of compliance with conditions (NOC/c) pathway.

A number of cancer medicines that were fast-tracked in Canada are now standard-of-care treatments • Source: Shutterstock

Most of the oncology medicines that received a conditional marketing approval in Canada between 2018 and 2021 have become standard-of-care treatments for their respective indications.

On the other hand, many of the confirmatory trials that are needed to fulfil the conditions of the approval are...

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More from Canada

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

‘Hope And Scientific Spillover’ – Cross-Atlantic HTA Alliance To Focus On Novel Benefits

 
• By Francesca Bruce

An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.

Health Canada Addresses Growing Diversity Of Co-Packaged Drugs

 
• By Vibha Sharma

The Canadian regulator says its current policy on identifying and labeling drug products in “kits” is insufficient to address the diverse types of co-packaged drug products that are entering the market.

More from North America

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.