Author: Pinky Mazumder
Antimicrobial resistance is currently recognized as a worldwide public health concern due to difficulty in treatment. In response, Health Canada is preparing to establish new regulatory tools and policies to help expedite the review process of therapeutic products indicated to target such pathogens and better address public health concerns. As a result on April 17th 2018, Health Canada proposed the Pathogens of Interest List (“Proposed List”) to inform sponsors on the pathogens involved in public health medical cases and which require therapeutic products for treatment.
The Proposed List is adopted from the Global Priority List of Antibiotic-Resistant Bacteria from the World Health Organization (WHO) and further extended to include pathogens specific to the Canadian population. The Proposed List includes pathogens such as Acinetobacter baumanii, Enterobacteriaceae spp., Salmonella spp., and Neisseria gonorrhea among others, however it does not include viral, fungal, parasitic, or vector-borne pathogens. It aims to focus on pathogens that can cause serious and/or life-threatening infections and for which limited treatment options are available. It is expected that Health Canada will periodically revise the Proposed List to reflect current advances in research and innovation efforts. The complete Proposed Pathogens of Interest List can be found in Annex A of the cited Notice.
In an effort to better meet public health needs, Health Canada will establish regulatory tools to accelerate the review process of therapeutic products that treat conditions caused by the pathogens included in the Proposed List. These therapeutic products (drugs or medical devices) may be novel products in development, or products that are already marketed outside of Canada. Sponsors can utilize the upcoming regulatory tools to submit market authorization applications with shorter review periods for therapeutic products targeting such pathogens. However, Health Canada currently advises sponsors to consider implementing various existing regulatory pathways when submitting such therapeutic products as they can also shorten the review period of the submission. Such regulatory pathways include:
· Priority Review
· Notice of Compliance with Conditions (NOC/c)
· Extraordinary Use of New Drugs (EUNDS)
· Access of Drugs in Exceptional Circumstances
· Drug Submissions Replying on Third-Party Data (Literature and Market Experience)
When filing a submission for a pathogen intended to address antimicrobial resistance, Health Canada suggests that the sponsor request a meeting to discuss the submission, and this meeting will also be prioritized.
For more information on the Pathogens of Interest List, please see the Health Canada Notice in the reference section below. Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media
Reference:
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