Fact Sheet - The New Risk-Based Approach for Natural Health Products

This content was archived on June 24, 2013.

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In May 2007, as part of Health Canada's Natural Health Products Regulatory Review initiative, a 60-day electronic consultation was held to provide stakeholders with the opportunity to share their views and thoughts on a number of topics pertaining to the regulation of natural health products (NHPs.)

During the consultation, the most prevalent comment raised by all stakeholder groups is the need to regulate NHPs proportional to risk and the need to address the current product licence application backlog. In response, Health Canada's Natural Health Products Directorate (NHPD) has developed a new Risk-Based Approach (RBA) to the regulation of NHPs. The RBA is intended to refine the NHP regulatory system to account for the unique risk profile of NHPs, while at the same time addressing the majority of the more specific issues raised during the consultation.

Proposed Modifications under the Risk-Based Approach

Under the RBA, modifications will be made to both product and site licensing requirements, to reflect the RBA's basic tenet of regulation proportional to risk. Changes to regulatory requirements will take into consideration such elements as the risks associated with various product classes and the availability of supporting evidence for safety, quality and efficacy/health claims. Likewise, compliance and enforcement activities and adverse reaction reporting will continue to be focussed on products which pose the greatest risk to the health of Canadians.

Product Licensing Modifications

The RBA envisions two classes of product licences. The class of a product will depend on the degree of certainty (that is, known and credible evidence) associated with a product's safety, quality or health claims:

• Class I - products and/or claims for which there are readily available, authoritative and high-quality sources of evidence. These sources of evidence, referred to as Pre-Cleared Information or PCI, relate to the efficacy, safety and quality of products and/or claims. Assessment of such products would be minimal as their safety and efficacy is already thoroughly documented.
• Class II - products and/or claims considered higher risk due to lack of existing evidence (e.g., a new and novel product). These products will require a thorough assessment of their safety, efficacy and quality.

Pre-Cleared Information

Pre-cleared information (PCI) can take on several forms including, but not limited to:

• widely recognized reference sources, such as pharmacopeias, monographs and labelling standards;
• expert opinion reports;
• international standards;
• information from other regulatory bodies, such as market authorization /licensing decisions; and
• other reputable sources.

Once identified and validated, PCI sources will assist the NHPD in evaluating product licence applications for "Class I" products. It is also intended that sources of PCI will be available to product licence applicants to expedite the application process. The NHPD has already begun work on several PCI initiatives, including:

• The Natural Health Products Online Solution, released on February 26, 2009, will ultimately give the NHPD a method for the electronic capture, storage and assessment of pre-cleared sources of credible evidence.
• Consultation with the NHPD's external Expert Advisory Committee (EAC) on potential additional sources of PCI, and how these sources can be used.
• Exchange of PCI with other international regulatory bodies is being explored.
• Abbreviated labelling standards for generalized health claims for a limited set of efficacy/health claims are being developed. These products and associated claims would fall within the "Class I" category of products.

Abbreviated Labelling Standards for Generalized Health Claims

Generalized health claims refer to health claims for lower-risk NHPs that are intended for self-limiting (minor) health conditions. The NHPD is exploring the use of standard labelling indications for these lower-risk claims as a tool to facilitate the licensing of certain types of NHPs.

An abbreviated labelling standard for a generalized health claim would consist of:

• an approved claim statement (e.g., "Used in Aromatherapy as a sleep aid");
• pre-approved reference material which contains supporting evidence for the generalized claim;
• ingredients to which the claim would apply; and
• relevant dosage and risk information.

The goal of developing these abbreviated labelling standards is to help NHP product licence applicants meet label requirements - that is, matching the claim to available evidence to ensure truthfulness and accuracy (e.g., "supports healthy bones" rather than "prevents osteoporosis"). These abbreviated labelling standards would be made available online to applicants via the Health Canada Web site.

Site Licensing Modifications

Currently there is no on-site evaluation of compliance with good manufacturing practices (GMPs) before or after a site licence is issued, unless the Health Products and Food Branch Inspectorate is notified of a potential post market compliance issue.

The RBA proposes that the site licence assessment process be modified to include some form of on-site verification of GMP compliance. Implementing a strengthened GMP verification process prior to the issuance of a site licence would enable Health Canada to identify risks and potential non-compliance issues much earlier in the process, thereby enhancing the safety of NHPs reaching the Canadian market.

An initial development of options is currently underway. Consultation with stakeholders will be undertaken before an option is chosen and implemented. Furthermore, any option chosen will be implemented in a phased manner to enable the industry to adapt to any the new changes.

The incorporation of a pre-market program for the verification of GMPs will provide the Canadian market with products that have been manufactured by companies for which Health Canada has verified that appropriate requirements for safety and quality are being followed. In addition, the verification of GMPs will ensure that products on the Canadian market have been manufactured according to GMPs, thus increasing assurance of product quality and safety and strengthening the NHP sector in Canada.

How Do I Get Involved?

Opportunities to provide input and feedback on any proposed changes to the product and site licensing requirements for NHPs will be communicated to interested stakeholders via the NHPD's Electronic Bulletin (NHPD e-bulletin). Subscribe to the e-bulletin.