Regulatory Control of Nano-Based Therapies in Canada

There is an increasing number of health products which fall under the definition of "nanomaterials" currently available in the marketplace in Canada. However, the safety assessment and risk management of these products pose challenges as the knowledge in the field is evolving. The objective of this paper is to highlight the present state of regulatory oversight for nanomaterial-based health products in Canada. To meet its statutory obligations to protect and promote the safety of Canadians, Health Canada continues to rely on the authorities of existing legislative frame work, which require the assessment of potential risks and benefits of products before they are authorized for sale. Health Canada has developed a Policy Statement on the Working Definition of Nanomaterial, which is now available on its website.