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Canadian Disinfectant Draft Guidance Document Open for 60-day Comment Period
(April 2013)

Health Canada’s Antimicrobial Products Division has announced the release of Draft Guidance Document: Disinfectant Drugs (2013) for a 60-day stakeholder consultation. Once finalized, the guidance document will replace Guidance Document: Disinfectant Drugs (2007). The new guidance document was developed in response to the withdrawal of the Canadian General Standards Board (CGSB) guideline CAN/CGSB 2.161-97 “Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surfaces and Medical Devices.” This draft guidance document provides a more comprehensive overview of the safety and efficacy requirements necessary to obtain market authorization of disinfectants and disinfectant sanitizers. In addition, the document proposes flexibility in the application for selected categories of hard surface disinfectants. This flexibility will assist in the reduction of unnecessary regulatory burden for low-risk disinfectants and create better harmonization with U.S. EPA regulatory guidelines.

Features of the draft guidance document include:

Well established test methods (e.g. Association of Analytical Communities standard methods) and more recent test methods (e.g. towelette protocols);
Inclusion of more detailed efficacy requirements to specify the recommended criteria for assessing disinfectant drugs, in tables based on
microorganism type;
The expansion of safety requirements to specify the recommended criteria for assessing disinfectant drugs;
The expansion of efficacy and safety data requirements for high-level disinfectants and chemosterilants intended for use on semi-critical and
critical medical devices to specify the recommended criteria for assessing higher-risk disinfectants;
The expansion and updating of efficacy and safety data requirements for contact lens disinfectants to specify the recommended criteria for assessing these
higher-risk disinfectants;
The addition and expansion of definitions;
The addition of an appendix describing the regulation of products containing antimicrobial ingredients in Canada with reference to the various regulatory
frameworks for cleaners, sanitizers, disinfectants, incidental additives and non-food chemical requirements; and,
 The removal of the Category IV Monographs, Labeling Standard and Labeling Guide: Food Processing Plant Sanitizers/Cleaners from the
body of the document.

The 60-day comment period is open from April 2, 2013- June 2, 2013. Please submit all comments to Health Canada, preferably in electronic form to D_Enquiries@hc-sc.gov.gc.ca or by fax or mail to the address:

Bureau of Gastroenterology,
Infection and Viral Diseases Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Finance Building, Address Locator 0202D1
101 Tunney’s Pasture Driveway
Ottawa, Ontario
Fax: 613-941-1183
Phone: 613-941-2566

For more information, please Contact TSG.
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