Notice - Health Canada's efforts to support innovative human therapeutic products to combat antimicrobial resistance (AMR)
November 15, 2018
Our File number: 18-118504-727
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 Federal Action Plan on Antimicrobial Resistance and Use in Canada, Health Canada is committed to facilitating regulatory approval for safe, effective, and high quality innovative products that help address the issue of AMR.
What is Health Canada Doing?
Health Canada is taking a phased approach to facilitate and expedite the regulatory review of drugs 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.
Phase I: Pathogens of Interest list
In the first phase, further to comments from stakeholders on a proposed Pathogens of Interest List which was published in spring 2018, Health Canada has finalized the Pathogens of Interest List (“the List”), which serves two purposes:
- To inform sponsors and manufacturers of the bacterial 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.
The List, which is included as Annex A to this Notice, has been updated and finalized as a result of the recent consultation. Informed by the World Health Organization, the United States Centers for Disease Control and Prevention and the Public Health Agency of Canada’s list of pathogens of greatest importance to public health in Canada, the Pathogens of Interest List is intended to be applicable to the Canadian context, while also including pathogens with global significance. The List focuses exclusively on bacterial 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. Viral, fungal, parasitic and vector-borne pathogens are not within scope at this time.
Health Canada will review the List on a periodic basis to ensure that advances in surveillance, research, and innovation efforts are reflected.
Phase II: New tools and policy approaches to support innovative human therapeutic products
Phase II of Health Canada’s approach will build on the Pathogens of Interest List as a basis for developing effective tools and policy approaches to support innovation in human therapeutic products. This policy work will be in support of and in parallel to the development of the 2017 Pan-Canadian Framework for Action on Tackling Antimicrobial Resistance and Antimicrobial Use.
As a key first step, consideration will be given to allowing priority review for drugs and diagnostic devices targeting pathogens on the Pathogens of Interest List in cases where the pathogen is not susceptible to therapies already marketed in Canada.
In addition to the Priority Review process, Health Canada currently has several options available for sponsors and manufacturers to facilitate and 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 using 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 / Medical Device Licence 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 C-difficile Infections.
Novel drug submissions or medical device applications targeting pathogens that are not represented on the List may still benefit from the above noted pathways. Sponsors and manufacturers who wish to file a submission or an application for a therapeutic product intended to address the issue of AMR are encouraged to schedule a meeting with Health Canada for further discussion.
In Phase II, Health Canada will continue to engage with stakeholders to explore ways to further incentivize and encourage the filing of drug submissions and medical device applications. Health Canada will also continue to work with international groups 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 Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Health Canada will provide key updates to stakeholders on progress made during Phase II development.
Please send your comments to:
Bureau of Gastroenterology Infection and Viral Diseases
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 0202B
Pathogens of Interest list
- Acinetobacter spp.
- Burkholderia cepacia complex
- Campylobacter spp.
- Clostridium difficile
- Enterococcus spp.
- Haemophilus influenzae
- Helicobacter pylori
- Mycobacterium tuberculosis (MTB) complex
- Neisseria gonorrhoeae
- Neisseria meningitidis
- Non-tuberculous mycobacteria species
- Pseudomonas spp.
- Salmonella spp.
- Shigella spp.
- Staphylococcus aureus
- Streptococcus agalactiae
- Streptococcus pneumoniae
- Streptococcus pyogenes
- Vibrio cholera
Health Canada will review the List on a periodic basis to ensure that advances in surveillance, research, and innovation efforts are reflected. While the above list is intended to inform sponsors and manufacturers of the pathogens that most urgently need to be addressed in the Canadian context, it is understood that pathogens that are not represented on this List may still benefit from an accelerated and/or flexible regulatory pathway. Sponsors and manufacturers are encouraged to engage with Health Canada who will determine the eligibility of unlisted pathogens on a case-by-case basis, as the AMR context continues to evolve.
The Proposed 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), 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 reflects comments provided by stakeholders during a public consultation period in spring 2018. It largely adopts the bacterial pathogens identified on the WHO Priority Pathogens List and the U.S. Food and Drug Administration List of Qualifying Pathogens due to the comprehensive nature, global significance and applicability within Canada of these lists. 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.
Health Canada has not identified specific resistance mechanisms within the inclusion criteria at this time. Therefore, 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
- 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
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