Health Canada has launched a new initiative in order to re-evaluate the current regulatory requirements for Consumer Health Products, like SPF’s and acne medications. The main goal of Health Canada is to accurately pair the amount of regulation to the risks associated with a product. In the past, Focal Point Research has estimated the cost of importing an SPF product into Canada at about $170’000 in year one. The cost of importing a cosmetic, however, was estimated at only $1000. Does this mean that SPF products bear 170 times the risk of a cosmetic product? Hopefully these new changes will help define that grey area in regulation, which SPF’s and other low risk drugs happen to fall into.
In its current state, Health Canada requires non-prescription drugs to follow the same regulations as prescription drugs (part C of the Food and Drug Regulations). This means that anti-bacterial toothpaste is required to follow the same regulatory requirements as heart medication. After years of consultation with industry, Health Canada agrees that these regulations are outdated for non-prescription drugs and do not account for a product’s relative benefit, harm, and uncertainty profile.
Although cosmetic and NHP regulations are expected to remain unchanged at the moment, we expect changes coming to non-prescription drugs aimed at balancing the regulatory requirements with these categories of products. Possible outcomes will be:
- Reduced or eliminated OTC drug importation requirements
- Faster assignment of DIN’s to OTC drugs
- Reclassification of SPF’s to a low risk framework
The process starts with an industry consultation which will run from November 27, 2014 until February 27, 2015. From there, we are hopeful changes will come into effect during 2015. For more information, please call 905-271-2709.