Health Canada introduces a reliance framework to accelerate access to treatments, beginning with pediatric and veterinary drugs.
Medical devices
The case against a US dental technology company suggests that regulators may be expanding scrutiny into medical device markets and digital health.
What the latest Regulatory Study means for government and innovators, and the challenge of strengthening the UK’s health system and industrial capability.
Coalition argues Council’s changes would increase complexity, costs, and administrative burdens, impeding EU innovation and competitiveness.
GRIP will partner with Informa Connect’s Pharmaceutical Compliance Congress: Canada to capture how compliance leaders are helping the industry innovate responsibly amid regulatory complexity.
The changes from the health regulator would give patients faster access to devices and align classifications of in vitro diagnostic (IVD) devices.
Initial reactions to the new regulatory pathway from medtech industry groups ranged from mostly positive to cautious.
A proposed rule change would require breakthrough devices to meet the same evidence standards as all other new technologies, reshaping reimbursement incentives starting in 2028.