The Emerging Viral Pathogen 2019-nCoV (Coronavirus) and what it means for Broad Spectrum Virucide Disinfectants

Author: Teri Dickinson, Manager, Regulatory Affairs, Dell Tech Laboratories Ltd.

On January 30, 2020 the World Health Organization (WHO) declared 2019-nCoV, as belonging to the Coronaviridae family and Betacoronavirus genus, similar to MERS Co-V and SARS Co-V, a public health emergency of international concern.  This lead Health Canada to invoke the claims against emerging viral pathogens policy within the disinfectant drugs guidance document.

Health Canada will permit manufacturers to provide communications to the public regarding the expected efficacy of certain Broad Spectrum Virucide disinfectant drugs against the emerging pathogen, 2019-nCoV: this includes communications through their web sites, toll free consumer information services, and similar media.

Disinfectants which have received market authorization for the following claims will be permitted to make efficacy claims against 2019-nCoV:

• Adenovirus type 5
• Bovine Parovirus
• Canine Parvovirus
• Poliovirus type 1
• specific claim against a Coronavirus within the Betacoronavirus genus

Note that Health Canada advises that ONLY indirect and “expected to be effective” and “likely to be effective” types of communications are permitted for 2019-nCoV, and that no direct claims against 2019-nCoV are to be made for DIN-authorized disinfectants, as these will be considered to be unsubstantiated. 

 References:

Guidance document - Safety and efficacy requirements for hard surface disinfectant drugs

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/safety-efficacy-requirements-hard-surface-disinfectant-drugs.html#b5