Human Drug Submission and Application Review

Human Drug (Pharmaceutical and Biological) Submission and Application Review Fees as of April 1, 2019
Fee Category Description Fee as of April 1, 2018 Fee as of April 1, 2019
New Active Substance Submissions in support of a drug , excluding a disinfectant, that contains a medicinal ingredient not previously approved in a drug in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate, or polymorph. $348,606 $355,579
Clinical or Non-Clinical Data and Chemistry & Manufacturing Submissions based on Clinical or Non-Clinical data and Chemistry & Manufacturing data for a drug that does not include a new active substance. $176,569 $180,101
Clinical or Non-Clinical Data Only Submissions based only on Clinical or Non-Clinical data for a drug that does not include a new active substance. $82,410 $84,059
Comparative Studies Submissions based on comparative studies (e.g. Clinical or non-clinical data, bioavailability, pharmacokinetic and pharmacodynamic data) with or without Chemistry & Manufacturing data for a drug that does not include a new active substance. $49,811 $50,808
Chemistry & Manufacturing Data Only Submissions based only on Chemistry & Manufacturing data for a drug that does not include a new active substance. $23,551 $24,023
Published Data Only Submissions based only on published clinical or non-clinical data for a drug that does not include a new active substance. $19,530 $19,921
Switch status from prescription drug to non-prescription drug Submissions based only on data that support the modification or removing of a medicinal ingredient listed in Schedule F of the Food and Drug Regulations (i.e. identical claim for existing drug). $47,421 $48,370
Labelling Only Submissions of labelling material. (i.e. does not include supporting clinical or non-clinical or Chemistry and Manufacturing data.) $3,174 $3,238
Administrative Submission Submissions in support of a manufacturer or product name change. $331 $338
Disinfectants Submissions and applications that include data in support of a disinfectant. $4,392 $4,480
Drug Identification Number application - Labelling Standard Applications attesting to compliance with a labelling standard or Category IV Monograph for a drug that does not include clinical or non-clinical data or chemistry and manufacturing data. $1,761 $1,797
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