Health Canada to Revise Disinfectant Drugs Guidance

Health Canada has released revised draft guidance concerning the safety and efficacy requirements necessary to obtain market authorization for disinfectants and disinfectant-sanitizers in Canada.

The draft proposes the use of updated test methods such as towelette protocols, as well as more detailed efficacy requirements such as expansion of the efficacy and safety data requirements for high-level disinfectants and chemosterilants intended for use on semi-critical and critical medical devices. 

The revisions were prompted by the withdrawal of the Canadian General Standards Board (CGSB) guideline concerning the Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surfaces and Medical Devices, which was referenced in the current guidance.  The deadline for comments is 60 days from the date of publication.

Health Canada also noted that the proposed revisions draw upon the long standing regulatory and scientific basis for the evaluation of disinfectant products by other regulators, most notably the United States Environmental Protection Agency (EPA) and the United States Food and Drug Administration (FDA), as well as North American Free Trade Agreement (NAFTA) guidance for the labeling of hard surface disinfectants, as well as the ongoing harmonization goals of the Organization for Economic Cooperation and Development (OECD).