Biomedical Engineering Reference
In-Depth Information
To identify a nano-based product/material, the sponsor will be asked to self-identify when their
application concerns a nanomaterial or “nanoproduct.” This is a relatively new requirement world-
wide, but one that is essential for the development of the inventory previously described.
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 the 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 informa-
tion, 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.
*
This language could well be part of the FDA information described early in the chapter. As in
the United States, Canada's 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 con-
sistent set of approaches
15.12 CONCLUSION
Global governments are proceeding cautiously. The United States, EU, and other nations are only
now commencing the first steps of regulatory development, the identification of what is to be regu-
lated, and the requirement or request to notify authorities of the identifiable nanoproducts being sold
and under what conditions.
As regulations are amended, applied, and interpreted, they may have a much greater effect on the
market for pharmaceuticals and medicinal products containing nanomaterials, and the rate at which
this is accomplished may cause a gap between countries that is not now apparent. The first possible
effect to monitor is notification/registration. If registration is pursued vigorously, the public and the
market could well learn of presently undisclosed applications of nanotechnology and other presence
of nanomaterials in products. It has been widely reported that many companies are utilizing nano-
materials in products, but being very circumspect in what they disclose because of the fear of litiga-
tion or adverse reaction from consumers, patients, and professionals. Full disclosure and, of course,
reports of real or perceived negative consequences from use could slow market development.
A more important factor will be if regulators ratchet up attempts to review products with nanoma-
terials prior to marketing. In the United States, the FDA has stated that the effect of the inclusion of
nanomaterials will be considered in products requiring preclearance because of their intended uses.
This could be an issue with prescription drugs, veterinary drugs, certain medical devices, and food
packaging materials, because of premarket approval requirements for many products. There are no
*
See
Health Canada. Drugs and Health Products. Nanotechnology-based health products and food. http://www.hc-sc.
gc.ca/dhp-mps/nano-eng.php.
