The U.S. FDA and Health Canada announced that they will roll out a pilot program that allows a medical device manufacturer to submit a medical device application to both agencies simultaneously for class II and class III medical devices.
Health Canada approved a device which Wayne, Pa.-based Teleflex Inc. described as the first commercially available biomechanical vascular device designed to close large holes in the femoral artery during endovascular catheterization procedures.
Links to electronic information may become a more common feature in Canadian prescription drug labeling, but electronic labeling is not expected to replace paper labels anytime soon.
New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders.
Even as the Biden administration pushes for drug imports from Canada as a way to help curb U.S. prescription drug prices, Canada is doubling down on its efforts to protect its supply of drugs and medical devices.
For the first time ever, Canada will be granting patent term adjustments beginning in January. That’s welcome news for the biopharmaceutical and med-tech industries, and it’s long overdue, Jeffrey Morton, a partner at Snell & Wilmer LLP, told BioWorld.
Health Canada is proposing amendments to the Food and Drugs Act that would provide greater oversight of the manufacture of drugs for export. Currently, facilities that manufacture or prepare drugs in Canada for use outside the country are not required to obtain a drug establishment license or to follow Canadian requirements for good manufacturing practices, and they are exempt from fees.
The U.S. isn’t the only country tossing COVID-19 vaccines due to potential cross-contamination of the drug substances manufactured at an Emergent Biosolutions Inc. plant.
Due to the pressing challenges of COVID-19, Health Canada is giving drug companies six more months to prepare for major reforms to its 1987 Patented Medicines Regulations.