Health Canada is working towards improving the way self-care products (cosmetics, NHPs, and non-prescription drugs) are regulated in Canada. These changes will be implemented via the “Self-Care Framework” to regulate low-risk self care products in the same way, and reduce the regulatory burden.

Health Canada published an updated timeline for the various phases in the framework’s implementation process.  Due to the upcoming Canadian Federal Election, there have been changes to the original schedule. After public consultations, the updated approach to regulating self-care products is targeted to be phased in over the next few years:

Phase I (Spring 2020) – Health Canada will introduce labelling amendments to Natural Health Products (NHPs). The changes will include improving the facts table for easier comparison between similar self-care products, as well as plain language on labels for consumers to easily understand.

Phase II (Spring 2020) – Health Canada will introduce a risk-based approach to regulating non-prescription drugs under the Food and Drug Regulations (FDR). The approach will include expedited pathways for lower-risk products such as sunscreens and acne products to align with regulations for self-care products with similar risk level.

Phase III (2021) – Health Canada will introduce regulatory amendments to address health claim evidence standards and extend regulatory oversight with a risk-based approach. Phase III will also seek additional controls for Health Canada such as having the ability to require recall or label change for all self-care products.

These changes to the regulatory framework are anticipated to support the safe and intended use of self-care products to help Canadians make more informed decisions when buying products. It is also intended to establish proportional regulatory rules based on risk, which would result in significant cost reduction for health care businesses..

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading Canadian regulatory and Health Canada consultants for Natural Health ProductsOTC DrugsCosmetics, and other personal care products.