Health Canada’s proposed three-tier framework for regulating self-care products will have implications for non-prescription drugs
Recognizing concerns in the current regulation of self-care products sold to Canadians – which consist of non-prescription drugs, natural health products, and cosmetics – Health Canada is proposing a new unified system of regulation for all three product categories.
All self-care products fall under the Food and Drugs Act, but they are currently controlled under three separate sets of regulations, which means that there are varying requirements for bringing these products to market. For instance, pre-marketing approval is not required for cosmetics, and manufacturers should notify Health Canada within 10 days of the date of first sale to provide information such as the ingredients in the product, its purpose, and the maker’s contact information.
The case is different for natural health products and non-prescription medications. For these, pre-marketing approval is needed, and manufacturers must demonstrate the safety and effectiveness of the product. The two product categories differ in the types of proof accepted: non-prescription medications require scientific evidence that back any claims made, while natural health products are allowed to submit a wider range of evidence, including non-scientific information such as proof of historical use.
There have been several concerns raised with the current system, according to Health Canada, including inconsistencies in the regulatory pathway, the level of evidence required, fees charged, and Health Canada’s post-market powers.
Under Health Canada’s proposed regime, regulation of self-care products will be rationalized based on a risk-based classification structure – the higher the risk posed to consumers, the more oversight a product will be subject to.
There will be three regulatory pathways to market: lower risk, moderate risk, and higher risk. The level of risk will determine the amount of information Health Canada must review, the degree of scrutiny required before the product can be made available to Canadian consumers, and the level of monitoring required for safety and compliance once released on the market.
For lower-risk products, such as vitamins, minerals, and cosmetics, Health Canada will not need to conduct claims reviews nor issue licenses. Products under this category are not allowed to make health claims, which would include claims about the diagnosis, prevention, or treatment of a health condition.
For moderate-risk products, such as pain relievers, cough and cold medicines, and allergy relief products, there would be some review of claims, and Health Canada would issue licenses based on scientific evidence of safety and efficacy.
Higher-risk products, such as those with new medicinal ingredients and those related to cardiovascular health, would go through a full review and approval by Health Canada prior to sale. Makers would be required to submit evidence to prove the safety, quality, and efficacy of such products, and any health claims would be subject to approval.
Health Canada has published a consultation paper discussing the unified, three-tier regulatory framework in more detail. Canadians are invited to submit comments until October 24.
Related stories:
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All self-care products fall under the Food and Drugs Act, but they are currently controlled under three separate sets of regulations, which means that there are varying requirements for bringing these products to market. For instance, pre-marketing approval is not required for cosmetics, and manufacturers should notify Health Canada within 10 days of the date of first sale to provide information such as the ingredients in the product, its purpose, and the maker’s contact information.
The case is different for natural health products and non-prescription medications. For these, pre-marketing approval is needed, and manufacturers must demonstrate the safety and effectiveness of the product. The two product categories differ in the types of proof accepted: non-prescription medications require scientific evidence that back any claims made, while natural health products are allowed to submit a wider range of evidence, including non-scientific information such as proof of historical use.
There have been several concerns raised with the current system, according to Health Canada, including inconsistencies in the regulatory pathway, the level of evidence required, fees charged, and Health Canada’s post-market powers.
Under Health Canada’s proposed regime, regulation of self-care products will be rationalized based on a risk-based classification structure – the higher the risk posed to consumers, the more oversight a product will be subject to.
There will be three regulatory pathways to market: lower risk, moderate risk, and higher risk. The level of risk will determine the amount of information Health Canada must review, the degree of scrutiny required before the product can be made available to Canadian consumers, and the level of monitoring required for safety and compliance once released on the market.
For lower-risk products, such as vitamins, minerals, and cosmetics, Health Canada will not need to conduct claims reviews nor issue licenses. Products under this category are not allowed to make health claims, which would include claims about the diagnosis, prevention, or treatment of a health condition.
For moderate-risk products, such as pain relievers, cough and cold medicines, and allergy relief products, there would be some review of claims, and Health Canada would issue licenses based on scientific evidence of safety and efficacy.
Higher-risk products, such as those with new medicinal ingredients and those related to cardiovascular health, would go through a full review and approval by Health Canada prior to sale. Makers would be required to submit evidence to prove the safety, quality, and efficacy of such products, and any health claims would be subject to approval.
Health Canada has published a consultation paper discussing the unified, three-tier regulatory framework in more detail. Canadians are invited to submit comments until October 24.
Related stories:
Health Canada allows exemption for marijuana testing
Access to abortion drug could be hampered by lack of coverage
