Notice - Health Canada's update to the Pathogens of Interest List and ongoing efforts to support innovative human therapeutic products to combat antimicrobial resistance (AMR)
March 5, 2021
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- The Issue
- What is Health Canada Doing?
- Policy approaches to support innovative human therapeutic products and diagnostics
- Contact us
- Annex A
- Inclusion criteria
Antimicrobial resistant (AMR) infections are becoming more frequent and increasingly difficult to treat. As a result, AMR is now recognized as a growing public health threat in Canada and around the world.
In support of the Pan-Canadian Framework on Antimicrobial Resistance and Antimicrobial Use, Health Canada is committed to facilitating regulatory approval of safe, effective, and high quality innovative products that help address the issue of AMR.
What is Health Canada Doing?
Pathogens of Interest List
In 2018, Health Canada published a Pathogens of Interest List (the List) following a public consultation with stakeholders.
Following another public consultation, the List (Annex A) was updated in 2021. The List contains bacterial and fungal pathogens that may cause serious, life-threatening infections in the Canadian population, and for which there are (or exists the potential to be) no or limited treatment options available.
The List serves two purposes:
- To inform sponsors and manufacturers of the pathogens creating the most urgent need for innovative therapeutic drugs and/or diagnostic devices in Canada; and
- To guide the development of new tools and policy approaches by Health Canada.
Health Canada uses the List as a selection criterion in expediting regulatory review of therapeutic products and medical devices for use in humans that help prevent, mitigate, treat or diagnose infection by pathogens for which there are limited treatment options.
These therapeutic products may come from novel drug or medical device development, as well as from sponsors and manufacturers seeking market authorization in Canada for therapeutic products already developed and marketed elsewhere. More information on the inclusion criteria for pathogens can be found in Annex A.
SARS-CoV-2 (the novel coronavirus that causes COVID-19) and other viral, parasitic, and vector-borne pathogens are not within scope of this updated List. In view of the current COVID-19 pandemic, Health Canada has already put in place a number of regulatory measures to facilitate the development of drugs and vaccines for COVID-19 to ensure timely access to safe and effective therapeutics. Please refer to Health Canada's website for more information on the Department's regulatory response to COVID-19.
Policy approaches to support innovative human therapeutic products and diagnostics
To foster the development of innovative human therapeutic products to combat AMR, Health Canada considers the List when determining priority review status for therapeutic products in cases where the pathogen is not susceptible to therapies already marketed in Canada. The Priority Review process for drug submissions and medical device applications aims to improve accessibility to these critical products.
In addition to the Priority Review process, Health Canada currently has several options available for sponsors and manufacturers to accelerate the regulatory review and approval processes in order to improve access to the drugs and medical devices that are needed the most by Canadians. Health Canada strongly encourages sponsors to use one or more of the regulatory pathways listed below to improve the availability of innovative therapeutic products on the Canadian market, specifically those targeting pathogens identified on the List.
- Notice of Compliance with Conditions;
- Extraordinary Use New Drugs;
- Access to Drugs in Exceptional Circumstances;
- Use of Foreign Reviews (for drug submissions); and/or
- Drug Submissions Relying on Third-Party Data (Literature and Market Experience).
Health Canada has also implemented an interim risk-based policy to give more access to Fecal Microbiota Therapy (FMT) treatment for patients suffering from recurrent Clostridioides difficile infections.
Health Canada cooperates with regulatory counterparts in other countries via a number of bilateral partnerships and international platforms such as the Access Consortium (including regulators from Australia, Canada, Singapore, Switzerland, and the United Kingdom) to address the global public health challenges and to enable timely approval of new medicines. Industry is encouraged to consider the Access Consortium or other international cooperation initiatives for new antimicrobial submissions and to contact the Department for more information.
Health Canada will continue to collaborate with international partners in order to align technical regulatory requirements for antimicrobial products with those of other international regulators to the extent possible. This includes participating on international fora such as the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) and the International Coalition of Medicines Regulatory Authorities (ICMRA). Health Canada fully supports the 2019 statement on AMR issued by ICMRA.
The Department has also taken steps to promote the research and development of diagnostic tools that identify and characterize antibiotic resistant bacteria and/or distinguish between viral and bacterial infections to address AMR infections. Health Canada has awarded more than $500,000 CAD to Canadian companies for the Phase 1 grant of the Point of Care Diagnostics to Combat Antimicrobial Resistance Challenge, and has made funding of up to $1 million CAD available for Phase 1 innovations that are eligible for a Phase 2 grant.
A summary of the feedback received during consultation is available on request.
Please send any questions or comments to:Bureau of Gastroenterology Infection and Viral Diseases
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 0202B
Updated Pathogens of Interest List (2021)
- Acinetobacter spp.
- Burkholderia cepacia complex
- Campylobacter spp.
- Clostridioides difficile
- Enterobacteriaceae (including but not limited to: Enterobacter spp., Klebsiella pneumoniae, Salmonella spp., and Shigella spp.)
- Enterococcus spp.
- Haemophilus influenzae
- Helicobacter pylori
- Mycoplasma genitalium
- Mycobacterium tuberculosis (MTB) complex
- Neisseria gonorrhoeae
- Neisseria meningitidis
- Non-tuberculous mycobacteria species
- Pseudomonas spp.
- Staphylococcus aureus
- Streptococcus agalactiae
- Streptococcus pneumoniae
- Streptococcus pyogenes
- Vibrio cholera
- Aspergillus spp.
- Candida spp.
- Cryptococcus spp.
The List was developed by comparing and synthesizing the World Health Organization (WHO, 2017), U.S. Food and Drug Administration (U.S. Federal Register, 2014), U.S. Centers for Disease Control and Prevention (CDC, 2013, 2019), Infectious Diseases Society of America (IDSA, 2012), European Innovative Medicines Initiative (IMI, 2012) and the Public Health Agency of Canada (PHAC, 2016) antimicrobial resistant pathogen lists. The List also incorporates feedback provided by stakeholders during public consultations in spring 2018 and fall 2020.
The updated List largely adopts the bacterial and fungal pathogens identified on the WHO Priority Pathogens List and the U.S. Food and Drug Administration (FDA) List of Qualifying Pathogens due to the comprehensive nature, global significance and applicability of these lists within Canada.
Criteria for selection by the WHO included factors such as the likelihood of the bacterial species to cause death, impact on healthcare and community, prevalence of resistance, 10-year trend of resistance, ease of transmission, preventability in hospital and community settings, treatability, and the potential availability of new drugs under development. Criteria for selection by the U.S. FDA were the impact on public health, pathogen growth rate and increase in resistance prevalence, and morbidity and mortality rates.
Selection criteria for the proposed pathogens to be included on Health Canada's updated List were: emerging pathogens that are resistant to antimicrobial drugs, pathogens that present significant human and public health threats, and pathogens that are prevalent in Canada and/or have the potential to be prevalent in Canada due to current disease trends and/or clinical practice. Health Canada has not identified specific resistance mechanisms within the inclusion criteria at this time.
It would remain the responsibility of the sponsor to demonstrate the clinical importance and need of the therapeutic product under submission review.
The List is presented in alphabetical order with no inherent ranking. Policies to facilitate and accelerate the regulatory review process, if applicable, would generally be applied on an equivalent basis.
- CDC (2013). Antibiotic Resistance Threats in the United States, 2013. Retrieved 2017
- IDSA (2012). Statement of the Infectious Diseases Society of America (IDSA) - Promoting Anti-Infective Development and Antimicrobial Stewardship through the U.S. Food and Drug Administration Prescription Drug User Fee Act (PDUFA) Reauthorization. Retrieved 2017
- IMI (2012). NewDrugs4BadBugs (ND4BB). Retrieved 2017
- PHAC (2016). Canada Communicable Disease Report - Volume 42-11.Retrieved 2017
- U.S. Federal Register (2014). Food and Drug Administration 21 CFR Part 317 Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act. Vol. 79, No. 108. Retrieved 2018
- Garner MJ, Carson C, Lingohr EJ, Fazil A, Edge VL, Trumble Waddell J (2015) An Assessment of Antimicrobial Resistant Disease Threats in Canada. PLoS ONE 10(4): e0125155. doi:10.1371/journal.pone.0125155
- WHO (2015). Implementing the End TB Strategy: The Essentials. Retrieved 2018
- WHO (2017). Global Priority List Of Antibiotic-Resistant Bacteria to Guide Research, Discovery, and Development of New Antibiotics. Retrieved 2017
- CDC (2019). Antibiotic Resistance Threats in the United States, 2019. Retrieved 2020
- Council of Canadian Academies (2019). When Antibiotics Fail. The Expert Panel on the Potential Socio-Economic Impacts of Antimicrobial Resistance in Canada. Retrieved 2020
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