Notice - Update on Health Canada’s efforts to support innovative human therapeutic products to combat antimicrobial resistance (AMR) and consultation on a proposed Pathogens of Interest List
April 17, 2018
Our File number: 18-100923-928
Antimicrobial resistant 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 facilitate 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 working to develop new tools and policy approaches, including new technical data requirements, which would facilitate and expedite the regulatory review for submissions involving new therapeutic drugs and/or devices that target important pathogens for public health.
Efforts are also underway to align Health Canada regulatory requirements for antibacterial 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 Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Proposed Pathogens of Interest List
In addition, Health Canada proposes to use a Pathogens of Interest List ("the Proposed List") (included as Annex A to this Notice), which would serve two purposes:
- Inform sponsors of the bacterial pathogens in most urgent need of innovative therapeutic drugs and/or devices in Canada; and
- Guide the development of new tools and policy approaches by Health Canada.
The Proposed List largely adopts the Global Priority List of Antibiotic-Resistant Bacteria issued by the World Health Organization (WHO, 2017), with additional pathogens specific to the Canadian context. It is focused 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.
More information on the inclusion criteria for specific bacterial pathogens can also be found in Annex A, with the Proposed Pathogens of Interest List. It is anticipated that Health Canada will revise the Proposed List and/or inclusion criteria on a periodic basis to reflect advances in surveillance, research, and innovation efforts.
Innovative human therapeutic products for the Canadian market to help prevent, mitigate, treat or diagnose infection by these pathogens may come from either novel drug or medical device development or sponsors seeking market authorization in Canada for therapeutic products already developed and marketed elsewhere.
Existing Toolkit to Facilitate Access to Critical New Human Therapeutic Products
Health Canada already has several options available for sponsors to facilitate and accelerate the regulatory review and approval processes in order to improve access to the drugs that are needed the most by Canadians. Health Canada strongly encourages sponsors to consider 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 Proposed List.
- Priority Review
- Notice of Compliance with Conditions
- Extraordinary Use New Drugs
- Access to Drugs in Exceptional Circumstances
- Fecal Microbiota Therapy and/or
- Drug Submissions Relying on Third-Party Data (Literature and Market Experience)
It is understood that novel drug submissions or medical device applications targeting pathogens that are not represented on the Proposed List may still benefit from an accelerated and/or flexible regulatory pathway. Sponsors intending 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. Such meetings will be prioritised to the extent possible.
We want to hear from you
You are encouraged to review the proposed Pathogens of Interest List and provide written comments by July 1, 2018. Health Canada is specifically interested in stakeholders' views on the following questions:
- Will the proposed Health Canada Pathogens of Interest List assist the development by sponsors of innovative priority therapies to combat AMR?
- Should any pathogens be added to or removed from the Proposed List to better reflect the Canadian context?
- How could this List be used to further stimulate the submission to Health Canada of new health products and facilitate their regulatory approvals?
- What new regulatory approaches or policy tools could be adopted that would facilitate a greater access to safe, effective and high quality therapies to help address the AMR issue?
Please send your questions or comments to:
Bureau of Gastroenterology Infection and Viral Diseases
Therapeutic Products Directorate
Health Products and Food Branch
Address Locator: 0202B
Proposed Pathogens of Interest List
- Acinetobacter baumanii
- Campylobacter spp.
- Clostridium difficile
- Enterococcus faecium
- Haemophilus influenza
- Helicobacter pylori
- Mycobacterium tuberculosis (MTB) complex
- Neisseria gonorrhea
- Pseudomonas aeruginosa
- Salmonella spp.
- Shigella spp.
- Staphylococcus aureus
- Streptococcus pneumoniae
*Enterobacteriaceae include: Klebsiella pneumonia, Escherichia coli, Enterobacter spp., Serratia spp., Proteus spp., Providencia spp., and Morganella spp.
Note: Updates to the List may occur in accordance with surveillance, research and innovation efforts. While the above list is intended to inform sponsors 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 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) (WHO, 2017), US 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 antimicrobial resistant pathogen lists (PHAC, 2016).
The Proposed List largely adopts the pathogens identified on the WHO priority pathogens list due to its comprehensive nature, global significance and applicability 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. The MTB complex was excluded from the WHO list as it is a globally established priority in need of innovative new treatments (WHO, 2015). Given its global and national importance, Health Canada has included the MTB complex on the Proposed List.
Clostridium difficile has been included on the List due to its clinical significance in the Canadian context. As C. difficile infection has become common in health care facilities in Canada and it is directly related to antibiotic use, the potential for increased resistance to commonly used therapies is high. Additionally, Health Canada is not proposing to identify 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 Proposed List is presented in alphabetical order with no inherent ranking. Policy flexibility and incentives, if available, 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
- 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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