Guidance on evaluation fees for human drugs and disinfectants: Applicable fees and fee groupings

On this page

• Applicable fees
• Fee categories
• Fee groupings

Applicable fees

The applicable fees are laid out in Schedule 1 of the Fees in Respect of Drugs and Medical Devices Order. As of April 1, 2021, fees will be adjusted once a year to keep up with inflation. The annual adjustment will be equivalent to the Consumer Price Index from the previous year.

Every fall, Health Canada will publish a notice of intent in the Canada Gazette specifying the fee amounts that will take effect the following April 1. We will also update the Canada.ca web site.

The fee is based on when the submission or application was filed. This is the date that Health Canada considers the submission or application has been completed to our standards.

The filing date and the date that we receive the submission or application are the same if the submission or application is accepted for preliminary examination as is, with no adjustments required.

However, the filing date will lag behind the date of receipt if we find that the submission or application is incomplete and the sponsor needs to provide additional information. For example, we receive a submission on March 15, 2021, but adjustments are required. If the submission is considered complete on April 5, 2021, then the fee in place on April 5 is the applicable fee.

Note: Submissions or applications are considered received on the next business day if they come in:

• after 5 pm Eastern Standard Time
• on a weekend
• on a statutory holiday

The fee structure for a drug submission or application review is hierarchical. Only the highest of all the possible applicable fees applies and will be charged.

If there's a change in the fee category while a submission or application is being reviewed, we will issue an invoice for the appropriate amount or apply a credit to the sponsor's account.

The following section provides additional descriptions and examples of the fee categories (in accordance with the Fees in Respect of Drugs and Medical Devices Order). Please refer to the following acronyms and their full names:

• ANDS: abbreviated new drug submission
• DIN: drug identification number
• DINA: drug identification number application for a pharmaceutical
• DINB: drug identification number application for a biologic
• DIND: drug identification number application for a disinfectant
• DINF: drug identification number application for a category IV monograph
• NAS: new active substance
• NDS: new drug submission
• SANDS: supplement to an abbreviated new drug submission
• SNDS: supplement to a new drug submission

Fee categories

New active substance

These are submissions in support of a drug, other than a disinfectant, that:

• contains a medicinal ingredient not previously approved in a drug for sale in Canada^{Footnote 1}
• is not a variation of a previously approved medicinal ingredient, such as a salt, ester, enantiomer, solvate or polymorph

Clinical or non-clinical data and chemistry and manufacturing data

These are submissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance.

The fee applies to the following submission types:

• NDS
• SNDS
• DINA
• DINB

Examples include:

• NDS for a non-NAS, such as an enantiomer, a subsequent entry NDS, a new fixed-dose combination product
• new dosage form requiring clinical studies
• new strength requiring clinical studies
• new formulation requiring clinical studies
• submission based on clinical data from published data and chemistry and manufacturing data (for example, submission relying on third-party data)
• a switch from prescription to non-prescription status (or vice versa) that may or may not involve a change in indication, dose or strength
  • supported by clinical data, non-clinical data or published data, and chemistry and manufacturing data
• subsequent entry biologics

Clinical or non-clinical data only

These are submissions based only on clinical or non-clinical data for a drug that does not include a new active substance.

This fee applies to the following submission types:

• NDS
• SNDS
• DINA
• DINB

Examples include:

• new indication or change in indication supported by clinical data, non-clinical data or published data only, not containing chemistry and manufacturing data
• changes to dosing and administration supported by clinical data, non-clinical data or published data only, not containing chemistry and manufacturing data
• any change to the text of the labelling that may increase the exposure levels of the drug, either by:
  • expanding the population that is exposed (related to market expansion) or
  • increasing individual exposure, such as a new indication, removal of contraindications or warnings and precautions supported by clinical data, non-clinical data or published data, and not containing chemistry and manufacturing data
• a switch from prescription to non-prescription status (or vice versa) that may or may not involve a change in indication or dose, supported by clinical data, non-clinical data or published data only, not containing chemistry and manufacturing data
• a change in product monograph format where the change includes presentation of additional or re-analyzed data that is not in a previously approved format

Comparative studies

These are submissions based on comparative studies (for example, 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.

This fee applies to the following submission types:

• NDS
• SNDS
• ANDS
• SANDS
• DINA
• DINB

Examples include:

• a change in formulation, new strength or new dosage form requiring a bridging bioavailability study
• any other change in chemistry and manufacturing supported by comparative bioavailability, pharmacodynamic or clinical studies
• ANDS or SANDS for a generic product supported by comparative bioavailability, pharmacodynamic or clinical studies in comparison to a reference product
• any other submission containing comparative bioavailability and pharmacodynamics data, including food effect studies

Chemistry and manufacturing data only

These are submissions based only on chemistry and manufacturing data for a drug that does not include a new active substance.

This fee applies to the following submission types:

• NDS
• SNDS
• ANDS
• SANDS
• DINA
• DINB

Examples include:

• any change in chemistry and manufacturing supported by chemistry and manufacturing data only, including those that include a waiver for bioavailability, pharmacodynamics or clinical studies, that does not contain any clinical, non-clinical or comparative data
• ANDS or SANDS for a generic product supported by pharmaceutical equivalence data only (such as injectable solutions) in comparison to a reference product
• data to support a bioequivalence waiver

Clinical or non-clinical data only, in support of safety updates to the labelling

These are submissions based only on clinical or non-clinical data supporting safety updates to the labelling materials for a new drug that does not include a new active substance.

This fee applies to the following submission types:

• SNDS
• SANDS

An example includes:

• any change to the text of the labelling resulting in safety information or reduced exposure to the drug being added (such as contraindications or warnings and precautions), supported by clinical data, non-clinical data or literature references and not containing comparative or chemistry and manufacturing data

Labelling only

These are submissions for labelling material. They do not apply to submissions for 'labelling only (generic drugs),' 'labelling only (disinfectants)' or 'DIN applications, labelling standards.'

Labelling only submissions include data supporting:

• a brand name assessment
• standardized or published test methods
• in vitro or in vivo photostability or applications for a DIN supporting 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)

This fee applies to the following submission types:

• NDS
• SNDS
• ANDS
• SANDS
• DINA
• DINB

Examples include:

• DIN applications that do not include supporting clinical, non-clinical or chemistry and manufacturing data (formerly known as DIN Form)
• DIN applications that include standardized/published test methods, or in vitro/in vivo photostability data
• NDS or ANDS that do not include supporting clinical, non-clinical or chemistry and manufacturing data, such as those for administrative submissions that also contain a component requiring label review, such as a new brand name
• SNDS or SANDS to remove an indication, dosage form or strength, with no supporting data provided
• SNDS or SANDS for changes to mock-up labels or content changes to the product monograph with no supporting data provided
• SNDS for a biosimilar for the extension of indication(s) where there is no additional data requested and that relies on the previously demonstrated similarity provided in the original biosimilar NDS
• an update to a new product monograph format limited to format changes only with no supporting data provided
• a submission requiring a brand name assessment
• significant changes exclusive to label design elements
• generic SNDS or SANDS proposing changes to the product monograph to be in line with the Canadian Reference Product (CRP), where the changes require label review, such as changes:
  • changes that require inner and outer labels and package mock-ups
  • changes to design elements of the labelling
  • changes to the brand name
  • product monograph changes that are based on a reference product other than the CRP, product monograph format updates, or removal of dosage form or strength

Labelling only (generic drugs)

These are submissions supporting a change to the labelling to be consistent with the CRP that do not include any additional labelling updates requiring a labelling assessment.

This fee applies to the following submission types:

• SNDS
• SANDS

Examples include:

• SNDS or SANDS for generic products filed for changes to the product monograph to be in line with the CRP only where additional changes requiring label review are not being proposed (see the section on 'Labelling only fee' for examples)
• SNDS or SANDS for generic products adding new safety information to be in line with the CRP where additional changes requiring label review are not being proposed
• SNDS or SANDS for generic products adding new indications to be in line with the CRP where additional changes requiring label review are not being proposed

Administrative submission (administrative processing)

These are submissions supporting 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 due to a licensing agreement being entered into by 2 manufacturers that do not require an assessment of labelling material or brand name, such as:
  • 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

This fee applies to the following submission types:

• NDS (including disinfectants)
• SNDS (including disinfectants)
• ANDS
• SANDS
• DINA
• DINB
• DIND
• DINF

Examples include:

• a change to the name of the manufacturer following a company merger, buyout or licensing agreement where there are no significant changes to the graphics or design elements on the labels or packages
• a change to the product name where there are no direct or indirect changes to claims (for instance, non-substantive claims), formulas or indications made and where the name change does not require a brand name assessment or where there are no implied claims

Note: If unapproved changes to the label have been submitted, the submission will not be eligible for processing under the administrative pathway.

Disinfectant, full review

These are submissions, other than those described for 'labelling only (disinfectants),' that include data in support of a disinfectant.

This fee applies to the following submission types:

• NDS
• SNDS
• DIND

An example includes:

• applications for a hard-surface disinfectant that includes supporting data

Not included are administrative, labelling only or labelling standard disinfectants, where the relevant fee would apply.

Labelling only (disinfectants)

These are submissions supporting either:

• changes to the labelling of disinfectants that do not require supporting data or
• safety updates for disinfectants that are new drugs or
• supporting a change in the manufacturer's name or brand name that requires a review of labelling material due to deviations from the previously authorized labelling or drug

This fee applies to the following submission types:

• NDS
• SNDS
• DIND

An example includes:

• labelling material that deviates from the previously authorized labelling or product

DIN applications, labelling standards

These are applications involving changes to brand names for non-prescription drugs. Changes include an attestation of compliance with a labelling standard or category IV monograph for a drug. They do not include clinical or non-clinical data or chemistry and manufacturing data.

This fee applies to the following submission types:

• DINA
• DINB
• DIND
• DINF

Examples include:

• non-prescription or disinfectant products only
• applications for non-prescription or disinfectant products attesting to compliance with a labelling standard or category IV monograph (DINF) for a drug where clinical or non-clinical data or chemistry and manufacturing data are not included

Not included are product name changes, which are covered by labelling only or administrative submission fees.

Fee groupings

Applications under Division 1 of the Food and Drugs Regulations may be grouped together resulting in 1 fee if the following conditions apply:

• applications are filed concurrently
• the reason for filing is the same for all applications
• all products in the group have the same brand name, manufacturer and active ingredient(s)

Sponsors should clearly identify they wish to group applications by listing concurrently filed applications on each cover letter.

A grouping can consist of products with different strengths, dosage forms or routes of administration.

The following table gives examples of products with varied brand names, active ingredients strengths and dosage forms. An explanation for acceptable product groupings is also provided.

Table 1: Sample product groupings

Example	Brand name	Active ingredient	Strength	Dosage form	Route
A	BrandName	active ingredient A	10 mg	tablet	oral
B	BrandName Plus	active ingredient A	10 mg	tablet	oral
		active ingredient B	100 mg
C	BrandName Injection	active ingredient A	5 mg/ml	liquid	IV
D	BrandName Plus Extra Strength	active ingredient A	20 mg	tablet	oral
		active ingredient B	200 mg
E	BrandName	active ingredient A	10 mg	tablet	oral
		active ingredient B	200 mg
		active ingredient C	2 mg
F	BrandName Anti-Inflammatory	active ingredient A	10 mg	tablet	oral
		active ingredient B	100 mg
G	BrandName SPF30	active ingredient A	2%	cream	topical
		active ingredient B	5%
H	BrandName SPF45	active ingredient A	4%	cream	topical
		active ingredient B	15%
I	BrandName Wipes	active ingredient A	10 mg	liquid	topical

A and C:

• same brand name (other than indicators of dosage form) and active ingredients
• may be "grouped" under a single application fee

B and D:

• same brand name (other than indicators of strength) and active ingredients
• may be "grouped" under a single application fee

E:

• different combination of active ingredients from the other possible "groups"
• must be submitted with its own application fee

F and I:

• different brand names from the other possible "groups" and from each other
• each must be submitted with its own application fee

G and H:

• same brand name but different strengths
• may be grouped