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Canada Consults On Customized Rules For Approving Unique Devices, Drugs

 
• By Vibha Sharma

Health Canada is inviting suggestions from stakeholders as it works on implementing a flexible approach for authorizing complex and novel health products. The regulator also draws up new clinical trial rules.

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Canada has proposed a flexible approach to authorize novel products

Health Canada is inviting stakeholder feedback on what factors it should consider in its planned implementation of a new flexible pathway for “truly unique” medical devices and drugs that are to be regulated as advanced therapeutic products (ATPs). In addition, the government department is seeking comments on amendments it is making to its clinical trial regulations to accommodate complex trial designs.

The ATP pathway will involve the use of “customized regulatory requirements” and will be reserved for “drugs or devices that...

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