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Drugs and Health Products

Nanotechnology-Based Health Products and Food

Nanotechnology

Nanotechnology is the application of scientific knowledge to manipulate and control matter in the nanoscale to make use of size- and structure-dependent properties and phenomena distinct from those associated with individual atoms or molecules or with bulk materials. The term "nanoscale" is defined as 1 to 100 nanometers (nm) inclusive.

Health Canada's Working Definition for the Products of Nanotechnology

As international consensus on a definition for the products of nanotechnology has not been reached yet, Health Canada has adopted a working definition for nanomaterials. The working definition is described in the Policy Statement on Health Canada's Working Definition for Nanomaterial that can be found on Health Canada's website.

The Policy statement will continue to be updated as the science evolves and international norms progress.

Applications of Nanotechnology

Nanotechnology and products derived from nanotechnology have a wide range of applications and the potential to impact many sectors, including the health and food sectors. In the health sector, the applications of nanotechnology impact new natural health products, medical devices, drugs, drug delivery systems, regenerative medicines and diagnostic devices for improved detection and treatment of illnesses. In the food sector, nanomaterials could be used to preserve food, improve nutritional values and enhance flavours.

Health Products and Food Branch (HPFB) involvement with Nanotechnology

HPFB participates in an interdepartmental Health Portfolio Nanotechnology Working Group which gathers information and acts as a discussion forum for issues related to nanotechnology. This working group contains members from Health Canada, the Public Health Agency of Canada (PHAC), and the Canadian Institutes of Health Research (CIHR). Additionally HPFB participates in the interdepartmental network chaired by Industry Canada.

Health Canada participates in a number of international initiatives, such as the Working Party on Manufactured Nanomaterials of the Organisation for Economic Co-operation (OECD), Development and the Technical Committee 229 of the International Organization for Standardization (ISO) and collaborates with international counterparts.

Authority

Health Canada adopted a broad working definition for nanomaterials to provide a consistent approach across several diverse regulatory program areas to identify regulated products and substances that may contain nanomaterials. The working definition enables the Department to establish internal inventories, to ask for additional information, and to integrate that new knowledge into regulatory decision making processes. The first step to assuring adequate risk assessment and risk management is to identify potential nanomaterials using the Working Definition as a tool.

Currently, there are no regulations specific to nanotechnology-based health and food products. Health Canada relies on authorities within existing legislative and regulatory frameworks, which require the assessment of potential risks and benefits of products to the health and safety of Canadians before they can be authorised for sale.

General guidance

According to Health Canada's working definition for nanomaterial, the term "nanoscale" means 1 to 100 nm inclusive. However, individual regulatory programs may request information above the 100 nm size range to an upper limit of 1000 nm in order to maintain flexibility to assess potential nanomaterials, including suspected nanoscale properties and phenomena. The 1000 nm cut-off attempts to separate characteristics attributable to macro-scaled materials from those of nanomaterials. In addition, for any regulated product or substance that contains nanomaterial and measures beyond 1 micron in size (for example, bundles of carbon nanotubes that are very long), regardless of the size, information may be requested for risk assessment purposes.

To identify a nano-based product/material the sponsor will be asked to self-identify when their application concerns a nanomaterial or 'nanoproduct'.

Recently the Drug Submission Application Form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation (HC/SC 3011) was revised to facilitate this process. Section 59 of the revised form allows the sponsor to identify Medicinal (Active) Ingredient(s) or Non-medicinal Ingredient(s) listed under Section 56 or 57 that are a nanomaterial. A similar approach has been adapted for Natural Health Products. It is planned that the Medical Devices Licence Application Form will also be revised to request the manufacturer to state whether their devices contain nanomaterials.

Health Canada encourages sponsors and other stakeholders to communicate with the responsible regulatory authority early in the development process, especially for combination products that are, contain or make use of nanomaterials. In order to identify and assess potential risks and benefits of nanotechnology based health and food products, the Department encourages manufacturers to request a pre-submission meeting with the responsible regulatory authority to discuss type of information that may be required for their product's safety assessment. In discussion with the sponsor the Department may require the following types of information, including but not limited to:

  • intended use of the nanomaterial, including any end product in which it will be used;
  • manufacturing methods;
  • characterization and physico-chemical properties of the nanomaterial, including identity, composition and purity;
  • toxicological, eco-toxicological, metabolism and environmental fate data that may be both generic and specific to the nanomaterial if applicable; and,
  • risk assessment and risk management strategies, if considered or implemented.

Given the range of products covered by Health Canada's regulatory responsibilities, the working definition was developed to be intentionally broad and will be applied more specifically in each regulatory program area. Future guidance specific to program areas and legislative and regulatory authorities will be developed in a manner that promotes a consistent set of approaches.

For additional guidance regarding any elements of the working definition and to address specific questions, consultation with the individual program areas is recommended.

Find more information about nanomaterials in the Science and Research section of our website.