Regulating Natural and Non-prescription Health Products: The Path Forward
On this page
- Background
- Red Tape Review
- Natural health product regulatory modernization
- Non-prescription drug regulatory modernization
Background
The Natural and Non-prescription Health Products Directorate is the Canadian regulatory authority for natural health products (NHPs) and non-prescription drugs (NPDs). We authorize NHPs and NPDs for sale in Canada and ensure that Canadians have ready access to a wide range of products for which safety, efficacy and quality standards are in place.
Health Canada introduced the Natural Health Products Regulations (NHPR) under the Food and Drugs Act on January 1, 2004. The NHPR created a distinct category for NHPs with tailored rules. The goal of the regulations is to ensure safety, efficacy, and quality, while enabling consumer access to these products.
Health Canada has heard from some industry stakeholders that recent initiatives aimed at strengthening oversight of NHPs have increased regulatory burden, and do not align the level of regulatory oversight with the level of risk that the products represent.
Health Canada regulates NPDs under the Food and Drug Regulations (FDR), to ensure NPDs are safe to use and the benefits outweigh the risks to people in Canada. The FDR define how NPDs are regulated, including their:
- safety
- efficacy
- quality
- labelling, and
- entry into the Canadian market.
The requirements set out in the FDR for NPDs are outdated and inflexible, with the same rules for both prescription and non-prescription drugs. These regulations may pose barriers to innovation and may be challenging for regulated parties to navigate.
Red Tape Review
In July 2025, the government launched a Red Tape Review that called on departments and agencies to review their regulations, including how they are administered, and develop reports detailing their progress.
On September 8, 2025, Health Canada and the Public Health Agency of Canada published a report on red tape reduction that outlines the actions Health Canada is committed to taking for both NHPs and NPDs.
The changes will simplify both application requirements and post-authorization obligations for NHPs and NPDs. Industry will have more flexibility to meet their regulatory obligations. This approach will also encourage more products to be brought to the Canadian market and support flexible, risk-based post-authorization vigilance.
Ultimately the goals are to reduce barriers for businesses, foster innovation, and protect the health and safety of people in Canada.
We are focusing on advancing the policy and regulatory changes highlighted in the report and in the Forward Regulatory Plan so that we can:
- increase flexibility in requirements
- ensure proportionate oversight
- facilitate easier market access
- reduce burden for industry and government
Natural health product regulatory modernization
We plan to amend the NHPR to reduce regulatory burden for both industry and government, while maintaining a level of oversight that is proportionate to both risk and uncertainty.
Specifically we are:
- introducing a simple registration process for certain NHPs
- reducing pre-market requirements where post-market oversight is more appropriate
- introducing flexible risk-based vigilance requirements for all NHPs
- amending labelling requirements to allow more flexibility
Non-prescription drug regulatory modernization
We plan to amend the FDR to introduce modern, flexible regulations for NPDs to fast-track their approval.
Specifically we are:
- introducing simplified requirements introducing a simple registration process for certain NPDs
- introducing flexible risk-based vigilance requirements