Fees for Examination of a Submission: Drugs for Human Use

Fees for Examination of a Submission: Drugs for Human Use as of April 1, 2020
Item Submission class Description Fee as of April 1, 2019 Fee as of April 1, 2020
1 New active substance Submissions in support of a drug, other than 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 $355,579 $400,288
2 Clinical or non-clinical data and chemistry and manufacturing data Submissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance $180,101 $204,197
3 Clinical or nonclinical data only Submissions based only on clinical or non-clinical data for a drug that does not include a new active substance $84,059 $90,864
4 Comparative studies Submissions based on comparative studies (e.g., clinical or non-clinical data, bioavailability data and data on the pharmacokinetics and pharmacodynamics of the drug) with or without chemistry and manufacturing data for a drug that does not include a new active substance $50,808 $53,836
5 Chemistry and manufacturing data only Submissions based only on chemistry and manufacturing data for a drug that does not include a new active substance $24,023 $27,587
6 Clinical or nonclinical data only, in support of safety updates to the labelling Submissions based only on clinical or non-clinical data, in support of safety updates to the labelling materials for a new drug that does not include a new active substance N/A $19,442
7 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) $48,370 Submission class discontinued
8 Labelling only Submissions, other than those described in item 9, 12 or 13, of labelling material, that include data in support of the following: brand name assessment, standardized or published test methods, in vitro or in vivo photostability or applications for a drug identification number in support of changes to brand names of non-prescription drugs (but not including examination of other supporting clinical or non-clinical data, comparative data, or chemistry and manufacturing data) $3,238 $3,816
9 Labelling only (generic drugs) Submissions in support of a change to the labelling to be consistent with the Canadian reference product that do not include any additional labelling updates requiring a labelling assessment N/A $2,010
10 Administrative submission Submissions in support of a change in the manufacturer’s name or brand name, including the following: changes in ownership of the drug, request for an additional brand name or changes resulting from a licensing agreement being entered into by two manufacturers that do not require an assessment of labelling material or brand name (e.g., post-authorization label changes filed by licensees to remain identical to licensor’s drug and post-authorization chemistry and manufacturing updates for drugs listed in Schedule C or D of the Food and Drugs Act) $338 $432
11 Disinfectant – full review Submissions, other than those described in item 12, that include data in support of a disinfectant $4,480 $5,712
12 Labelling only (disinfectants) Submissions in support of changes to the labelling of disinfectants that do not require supporting data, submissions in support of safety updates for disinfectants that are new drugs or submissions in support of a change in the manufacture’s name or brand name that requires a review of labelling material due to deviations from the previously authorized labelling or drug N/A $2,507
13 Drug identification number application - labelling standards Applications, including those that pertain to changes to brand names for non-prescription drugs, that include an attestation of 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 $1,797 $1,616
14 Published data only Submissions based only on published clinical or non-clinical data for a drug that does not include a new active substance $19,921 Submission class discontinued

Please visit Fees for Human Drugs for relevant guidance documents and forms.

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