With the recent announcement that Coronovirus has gone pandemic, consumers are flooding supermarkets, and preparing for indeterminate periods of self-isolation. All the while the marketplace is reeling, seeing demand for products aimed at preventing infection skyrocket. As a result, antimicrobial products such as Human-Use Antiseptic Drugs (hand sanitizers), are clearing off the shelves. In many ways, companies within the health products industry are at the forefront of the battle against this new and growing threat to the health and safety of Canadians. However, companies wishing to go to market with infection control products that are otherwise safe and effective must still meet the regulatory requirements for product licensing.

The aim of this article is to help both individuals and companies alike learn about the regulatory requirements needed to enter the Canadian market with Human-Use Antiseptic Drugs.

What are Human-Use Antiseptic Drugs (HUADs)?

An antiseptic product as per Health Canada is “any product that inactivates, prevents, or arrests the growth of microorganisms with the inherent intent to mitigate or prevent disease”. The scope of this definition applies to Human-Use Antiseptic Drugs (skin products) intended for human use. It also applies to all products which make claims of efficacy against “specific organisms, persistence, log reduction or % reduction and/or antiviral claims”.

There are several categories of HUADs:

• Personal Domestic Use – Described as topical products used domestically to try to reduce “transient organism” concentration on the skin.
  • Monograph – Antiseptic Skin Cleansers. Described as daily use consumer skin products.
  • Non-Monograph – Products not captured under the personal domestic use monograph. Examples include consumer-use first-aid antiseptic products for minor wound cleaning.
• Personal Commercial Use – Meant for use by the general public in commercial or institutional settings.
• Food Handler Use – Meant for use by food handlers in commercial or institutional settings including restaurants (both-dine in and fast food establishments), supermarkets, and food processing plants.
• Healthcare Use – Meant for use by individuals in healthcare settings such as in-patient and out-patient centres, clinics, long-term care facilities, and hospitals. These products include professional hygienic handrubs & handwashes, surgical handrubs & handwashes, and preoperative skin preparations.

The types of ingredients used in the formulation of these products will determine whether or not they will require a Natural Product Number (NPN) or a Drug Identification Number (DIN) from the Natural and Non-prescription Health Products Directorate (NNHPD). For a list of these ingredients please refer to the official guidance document here: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/human-use-antiseptic-drugs.html

Types of Health Claims and How They Are Obtained

For the purposes of this article we will be focusing on the claims specific to Personal Domestic & Commercial Use Products:

• Antiviral – Defined as a reduction specific to viral pathogens. Requires In-Vitro testing for efficacy against indicator organisms such as Polio Virus type 1, Adenovirus, Herpes simplex Type I, etc.
  **Subject to pre-market assessment
• Log or % Reduction Claims – Defined as a quantified reduction in the pathogen (either log or percent). In order to comply, manufacturers must submit supporting evidence of the reduction in indicator organisms from pathogens (where applicable) including bacteria, mycobacteria, fungi, and viruses.
  **Subject to pre-market assessment
• Organism Specific – Defined as a reduction in a specific organism such as bacteria, fungi, mycobacteria, or viruses. Manufacturers must submit supporting evidence of reduction in indicator organisms from the specific class of organism they wish to claim.
  **Subject to pre-market assessment
• Persistence Claims (only applicable to bacteria) – defined as a product delivering a longer action than the immediate reduction of the microorganism on the hands and must be substantiated by appropriate test method.
  **Subject to pre-market assessment
• Time-Kill Claims – Antiseptic products already have a minimum time-to-effect (kill). These minimums are 30 seconds for waterless handrubs and 60 seconds for washes/scrubs using water. Manufacturers must demonstrate a significantly shorter time-to-effect while maintaining clinical relevance in order to use time-kill claims.
• New Active Ingredient or Combination of Ingredients – In order to make this claim manufactures must prove their product is effective against bacteria & fungi.
  **Subject to pre-market assessment
• Sterility Claims – Any antiseptic product claiming sterility must undergo a chemical and manufacturing review.

**For personal domestic & commercial use products: In vitro tests are only recommended for product applications involving fungal and/or viral testing.

In light of the recent Coronavirus pandemic, Health Canada has prioritized all HUAD product licence registrations. If you or your company is looking to apply for a HUAD product licence, now is the time act. Contact dicentra today to get your application started.