As previously reported, the Federal Court quashed a second decision by the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to Médunik
In a decision released on
In the redetermination, the Minister provided two grounds for concluding that the data protection regime did not apply to RUZURGI. First, FIRDAPSE had not yet been designated an innovative drug at the time the NDS for RUZURGI was filed (the timing issue). Second, while the product monograph for RUZURGI referred to the FIRDAPSE studies (carcinogenicity and reproductive and development toxicity studies), those studies were not relied upon by the
The
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The Federal Court erred in finding that the Minister conflated reliance on information by an NDS applicant, on the one hand, and by the Minister, on the other. It is reasonable to look into the TPD's analysis of safety and efficacy to conclude that Médunik did not rely on the FIRDAPSE studies.
- The additional documents not considered by the Minister in the redetermination, even if relevant, do not support the Federal Court's conclusion that Médunik in fact relied on the FIRDAPSE studies to support its NDS. It is likely that the FIRDAPSE studies were mentioned in the RUZURGI product monograph to provide publicly available safety information concerning a similar drug.
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