A new approach to natural health products

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Introduction

Natural health products (NHPs) are regulated under their own specific regulations, the Natural Health Products Regulations, which take into account the unique nature and properties of these products.  Since 2004, Health Canada has authorized over 50 000 NHPs for sale (compared with about 7 000 authorized prescription medications).

As part of our ongoing commitment to continuous improvement, the Government of Canada has developed a new approach to NHPs.   We have heard fromstakeholders, consumers, and parliamentarians that there is a need for increased access to products while maintaining consumer safety, and for the reduction of unnecessary administrative burden for companies trying to bring safe products to market.

What follows is information on NHPs and the plan for a more efficient, flexible regulatory approach.

What is an NHP?

An NHP is an expression used in Canada to refer to a group of health products that include:

• vitamin and mineral supplements;
• herbal and other plant-based health products;
• traditional medicines, such as traditional Chinese medicines;
• homeopathic medicines;
• probiotics and enzymes; and
• some personal care products like toothpastes that contain natural ingredients.

NHPs are regulated according to the Natural Health Products Regulations which came into effect on January 1, 2004.

What is the current situation for NHPs?

Since 2004, Health Canada has authorized over 50 000 NHPs for sale in Canada as well as 1 250 manufacturing sites. 

As of 2012, there remains, however, a backlog^{Footnote 1} of applications for products.   When the Natural Health Products Regulations came into effect in 2004, the majority of products that were already on the market created an instant number of unprocessed applications.  The Department is making changes to its administrative processes to ensure that applications are processed efficiently going forward and to clear the backlog by February 2013. These are explained in further detail below.

What is the new approach to regulating NHPs?

This new approach will achieve a balance that ensures safety and consumer access while enabling industry innovation and growth. 

Pathway for licensing NHPs

In May 2012, Health Canada published for consultation revised guidance documents detailing the pathway for licensing NHPs. These guidance documents equip stakeholders with the straightforward information and tools they need to bring products to market, and provide innovative pathways for licensing products.  The consultation on these guidance documents is scheduled to end August 21, 2012, and they will be finalized shortly after.

Product licensing

Review times for applications will be based on how much we know about a product's benefits and risks, relying on a library of information amassed from the authorization of over 50 000 NHPs.

This means that products about which we know the most will be reviewed in a shorter period of time than those for which we have less certainty.  Our evaluation efforts will be focused on the latter group.

A new three-class system will enable us to determine how much review time a product needs, starting with Class I products that will move through the system the most quickly up to the more complex class III products, which will require more review before approval.  More information is available in Annex I.

Natural Health Products Directorate product licence applications: 
level of certainty* and level of pre-market review required
(* how much is known about product - pre-cleared information)

More pre-cleared information developed = less review required

Site Licensing

A site licence helps to assure the quality of a product before it goes onto the market. Before a company can legally manufacture, package, label or import an NHP for sale in Canada, the company must obtain a site licence, by showing that they follow Good Manufacturing Practices (GMPs) for product quality and safety.

Under the current model, a company's quality assurance person demonstrates compliance with GMPs by providing supporting documents and information to Health Canada.  Under the proposed model, there are 2 prongs: (1) required on-site inspection for companies demonstrating critical non-compliance; and (2) optional on-site inspection by a recognized 3rd party to obtain a "seal of approval" for exportation and marketing purposes.

Health Canada will be consulting on this proposal in fall 2012.

Compliance and enforcement

Health Canada will be working with stakeholders on compliance and enforcement for NHPs to continue to ensure that products on the market are safe for consumers.  There will be consultation with stakeholders in fall 2012.

What impact does the new approach have on product safety?

Shortened review time does not change the measures in place to protect consumer safety. The level of evidence required to demonstrate safety remains the same, and products will continue to be labelled with required cautionary statements, e.g. potential adverse reactions and interactions with other products; warnings for certain populations like pregnant women; duration of use; etc.

Health Canada will also continue to focus its post-market activities for NHPs on situations that pose risks to the health and safety of Canadians, e.g., poor manufacturing, adulteration (e.g. addition of prescription and non-prescription drugs to NHPs), or products making claims not substantiated by evidence.

The regulatory requirement for a company to submit reports of serious adverse reactions will not change, and we will also continue to collect, track, and analyze adverse reactions to NHPs through the Canada Vigilance Program. When analysis of this adverse reaction information shows that there is a need to take action to protect the health and safety of Canadians, Health Canada can take a range of steps such as changes to product labelling, distribution of information to consumers and health professionals, and, in more serious cases, removal of a product from the market. 

Results to date

Health Canada has been making improvements to its administrative processes for product reviews. There have already been significant gains. The number of product applications completed per month has increased from 793 in October 2011 to 1 657 in March 2012 (109%). Operational efficiencies have also resulted in an increasing number of backlog licence applications completed monthly, from 145 in October 2011 to 431 in May 2012. 

Next steps

Health Canada will be consulting on key elements of this new approach to NHPs in fall 2012. The Department will also continue to implement administrative efficiencies, within existing regulatory authorities, in the months to come.

Annex I: Three classes of NHPs

Classes are based on the level of certainty associated with the product (i.e., how much is known about it) with a corresponding level of pre-market review.

What we know about a product is based on a library of information amassed from the authorization of over 50 000 NHPs.

Class 1: high level of certainty, lowest level of pre-market review

• applicants attest to existing information pre-cleared by Health Canada
• examples: vitamins and minerals, various herbal products
  • Though the risks associated with various class I products vary, the level of certainty is the same.
• current performance target: 60 days; proposed target: 10 days

Class 2: medium level of certainty, medium level of pre-market review

• evidence such as published literature required in addition to pre-cleared information
  • example: existing authorized product with a new claim about what the product can be used for
• current performance target: 180 days; proposed target: 30 days

Class 3: low level of certainty, highest level of pre-market review

• clinical trial evidence and full pre-market assessment
• examples: a new product claiming to cure cancer or Multiple Sclerosis
• current performance target: 180 days; proposed target: 180 days