Health Canada has announced that there will be updates to the approach to regulating self-care products as part of their 2020-2022 Forward Regulatory Plan. The self-care framework will roll out in phases over the coming years:
Phase I – Target Spring 2021 will include amendments to the Natural Health Product (NHP) Regulations to improve labelling of NHPs.
Phase II – Target Spring 2022 will include amendments to introduce for consultation a risk-based approach to regulatory oversight for non-prescription drugs such as expedited pathways for lower-risk products.
Phase III – To introduce for consultation, regulatory amendments to address evidence standards for similar health claims, extending risk-based regulatory oversight, and additional powers for Health Canada to require a recall or label change for all self-care products.
There will be an opportunity to provide comments on Phase I of the Self-Care Framework during the Canada Gazette, Part I, public comment period, which is expected to take place in spring 2021 and last 70 days.
For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.