1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>Canada

Canada Develops RWE Guide Anticipating Increased Submissions

 
• By Vibha Sharma

New Canadian guidance is expected to help drug sponsors collect high-quality, real-world data that meets international evidence requirements for approval. It focuses on good practices for protocol development and data collection.

ICON_Featured_Image_1200x675.jpg
Health Canada Wants To Optimize The Use Of Real-World Evidence • Source: Shutterstock

Health Canada has developed a guidance document to help drug sponsors generate real-world evidence (RWE) that is consistent with the regulatory standard of evidence in place in Canada and internationally.

The guidance document includes an overview of some of the issues that sponsors should address in protocol development, and characterizes some of the data quality concerns observed within submissions...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

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

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.