Health Canada implements updated bioequivalence and biowaiver evaluation templates: Notice
Date: October 6, 2026
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Background
Health Canada continues to align our regulatory requirements with International Council for Harmonisation (ICH) standards. For example, we recently implemented 3 ICH guidelines:
- Bioequivalence for immediate release solid oral dosage forms (M13A)
- Biopharmaceutics classification system (BCS)-based biowaivers (M9)
- Bioanalytical method validation and study sample analysis (M10)
We updated the following templates to help sponsors prepare submissions that align with these guidelines:
- Comprehensive Summary – Bioequivalence (CS-BE) Template
- reflects data requirements harmonized under ICH M10 and ICH M13A
- Biopharmaceutics Classification System (BCS)-based Biowaiver Evaluation Template
- reflects data requirements harmonized under ICH M9
We notified industry about the updated templates in April 2026. These templates are identified as version 2.
Find more information, including guidances, on bioavailability and bioequivalence.
Updated templates now in effect
You should use the updated templates as of the date of this notice.
The templates are required for submissions, such as abbreviated new drug submissions (ANDSs), that contain:
- bioequivalence studies or
- requests for a BCS-based biowaiver
We will send you a "screening clarification request" if you use an older version. You then have 30 calendar days from the date of the request to send in the updated template. If you can't provide us with version 2 within this period, we may issue a screening rejection letter.
How to obtain the updated templates
Email us to request the relevant template at no-reply.PDD.Publications.DMP.non-reponse@hc-sc.gc.ca.
You must indicate which template you want in the subject line:
- For the updated CS-BE template:
- Subject line: Comprehensive Summary - Bioequivalence (CS-BE) Template
- For the updated BCS-Based Biowaiver Evaluation Template:
- Subject line: Biopharmaceutics Classification System (BCS)-Based Biowaiver Evaluation Template
Be sure not to change the template format.
Contact us
If you have questions, email the Bureau of Pharmaceutical Sciences, Health Products and Food Branch, at BPS_enquiries@hc-sc.gc.ca.