We previously reported Health Canada's March 27, 2023 consultation on its proposed application of the definition of Canadian reference product (CRP) based on "Dormant Status" under s. C.08.001.1(b) of the Food and Drug Regulations (FDR).
On January 26, 2024, Health Canada published a notice confirming the Department will apply the definition of CRP consistent with its proposal:
In cases where a drug that would otherwise have been identified as the CRP in accordance with paragraph C.08.001.1(a) is listed as 'Dormant' in the DPD, Health Canada confirms that this 'Dormant' status can be considered to be evidence that the drug is "no longer marketed", as used in paragraph C.08.001.1(b) of the FDR.
While the approach remains the same as proposed, Health Canada clarified the following:
If a generic manufacturer files a submission under the ANDS or AEUNDS pathway using a CRP identified in accordance with paragraph C.08.001.1(b) and it is determined (after receipt of the submission) that the drug listed as 'Dormant' in the DPD, which would otherwise have been identified as the CRP in accordance with paragraph C.08.001.1(a), had restarted sales and was therefore 'marketed' on the date of submission filing, the ANDS or AEUNDS may be requested to be withdrawn and/or may be subject to a negative decision. This withdrawal and/or negative decision would be based on the ANDS' or AEUNDS' being ineligible to rely on an alternate CRP under paragraph (b) of the CRP definition due to the marketed status of the CRP identified in accordance with paragraph C.08.001.1(a) at the time of ANDS or AEUNDS filing. The manufacturer would then be requested to file a new submission using the CRP identified in accordance with paragraph C.08.001.1(a) (and would be subject to any applicable fees). [Emphasis added.].
Health Canada provided separate notable clarifications including:
- the application of the definition of CRP only applies to abbreviated new drug submissions (ANDSs) and abbreviated extraordinary use new drug submissions (AEUNDSs) and not to biosimilar drugs subject to a new drug submission;
- the assessment of whether a proposed alternate reference product can be relied upon in an ANDS or AEUNDS will be based on the marketing status of the CRP at the time of filing i.e., changes to the marketing status of the CRP post-ANDS or AEUNDS filing will not affect the assessment or require re-assessment;
- Where an ANDS or AEUNDS seeks to rely on a CRP identified in accordance with paragraph C.08.001.1(a), but at the time of filing the CRP identified in accordance with paragraph C.08.001.1(a) is no longer marketed, the ANDS or AEUNDS may continue to rely on that CRP pursuant to paragraph (b) of the CRP definition.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
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