Supplementary Information Tables: 2016-17 Departmental Results Report
User Fees, Regulatory Charges and external fees
- Reporting on the User Fees Act
- Fee Right to Sell Drugs Fee
- Drug Establishment Licensing Fees
- Drug Submission Evaluation Fees (Pharmaceuticals and Biologic Products)
- Medical Device License Application Fees
- Fee for Right to Sell a Licensed Medical Device
- Medical Device Establishment Licensing Fees
- Veterinary Drug Evaluation Fees
- Fees charged for filing a claim for exemption under the Hazardous Materials Information Review Act
- Pest Control Product Application Examination Service
- Right or Privilege to manufacture or sell a Pest Control Product in Canada and for Establishing a Maximum Residue Limit in relation to a Pest Control Product
- Fees for processing requests filed under the Access to Information Act
Reports on the User Fees Act
Table 2 A 2016-2017
Fee Right to Sell Drugs Fee
Fee name
Fee Right to Sell Drugs Fee
Fee type
Regulatory (R)
Fee-setting authority
Financial Administrative Act
Year introduced
1995
Year last amended
2011
Performance standard
120 calendar days to update the Drug Product Database following notification
Performance results
100% within 120 calendar days
Other information
See Note 1
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 12,512,205 | 12,015,179 | 55,933,282 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 12,525,575 | 61,809,399 |
| 2018-19 | 12,776,086 | 64,409,780 |
| 2019-20 | 13,031,608 | 68,379,579 |
Drug Establishment Licensing Fees
Fee name
Drug Establishment Licensing Fees
Fee type
Regulatory (R)
Fee-setting authority
Financial Administrative Act
Year introduced
1998
Year last amended
2011
Performance standard
250 Calendar days to issue / renew license
Performance results
Average number of days: 108 days
Other information
See Note 1
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 15,808,383 | 16,766,144 | 21,179,125 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 17,234,551 | 21,602,708 |
| 2018-19 | 17,579,242 | 22,034,762 |
| 2019-20 | 17,930,827 | 22,475,457 |
Drug Submission Evaluation Fees (Pharmaceuticals and Biologic Products)
Fee name
Drug Submission Evaluation Fees (Pharmaceuticals and Biologic Products)
Fee type
Regulatory (R)
Fee-setting authority
Financial Administrative Act
Year introduced
1995
Year last amended
2011
Performance standard
Review 1 (average time in calendar days)
Pharmaceuticals
NAS: NDS = 300
CLIN C&M: NDS = 300
CLIN C&M: SNDS = 300
CLIN : NDS = 300
CLIN: SNDS = 300
CLIN: DIN A = 210
COMP C&M: ANDS = 180
COMP C&M: NDS = 180
COMP C&M: SANDS = 180
COMP C&M: SNDS = 180
COMP C&M: DIN A = 210
C&M: ANDS = 180
C&M: NDS = 180
C&M: SANDS = 180
C&M: SNDS = 180
C&M: DIN A = 210
PUBLISHED DATA: SNDS=300
PUBLISHED DATA: DIN A=210
Rx to OTC Switch: NDS = 180
Rx to OTC Switch: SNDS = 180
DISINFECTANT: NDS-D = 300
DISINFECTANT: SNDS-D = 300
DISINFECTANT: DIN D 210 = 210
DISINFECTANT: DIN D 180 = 180
LABELLING ONLY : NDS=60
LABELLING ONLY : SNDS=60
LABELLING ONLY : ANDS=60
LABELLING ONLY : SANDS=60
LABELLING ONLY : DIN A=180
LABEL STANDARD: DIN A=45
LABEL STANDARD: DIN D=45
LABEL STANDARD: DIN F=45
ADMINISTRATIVE: ANDS = 45
ADMINISTRATIVE: NDS = 45
ADMINISTRATIVE: SNDS = 45
ADMINISTRATIVE: SANDS = 45
ADMINISTRATIVE: DIN A = 45
ADMINISTRATIVE: DIN D = 45
ADMINISTRATIVE: DIN F = 45
Biologics
NAS: NDS = 300
CLIN C&M: NDS = 300
CLIN C&M: SNDS = 300
CLIN C&M: DIN B = 210
CLIN: NDS = 300
CLIN: SNDS = 300
C&M: ANDS = 180
C&M: SANDS = 180
C&M: SNDS = 180
C&M: DINB = 210
COMP C&M: ANDS = 180
COMP C&M: SNDS = 180
COMP C&M: DINB = 210
LABELLING ONLY: NDS = 60
LABELLING ONLY: SNDS = 60
PUBLISHED DATA: SNDS = 300
ADMINISTRATIVE: NDS = 45
ADMINISTRATIVE: DINB = 45
Performance results
Review 1 (average time in calendar days)
Pharmaceuticals
NAS: NDS = 244
CLIN C&M: NDS = 285
CLIN C&M: SNDS = 282
CLIN : NDS = N/A
CLIN: SNDS = 272
CLIN: DIN A = N/A
COMP C&M: ANDS = 170
COMP C&M: NDS = 180
COMP C&M: SANDS =176
COMP C&M: SNDS = 179
COMP C&M: DIN A = 204
C&M: ANDS = 177
C&M: NDS = 179
C&M: SANDS = 146
C&M: SNDS = 158
C&M: DIN A = 203
PUBLISHED DATA: SNDS = 263
PUBLISHED DATA: DIN A= 196
Rx to OTC Switch: NDS = N/A
Rx to OTC Switch: SNDS = N/A
DISINFECTANT: NDS-D = N/A
DISINFECTANT: SNDS-D = N/A
DISINFECTANT: DIN D 210= 205
DISINFECTANT: DIN D 180 = N/A
LABELLING ONLY : NDS= 54
LABELLING ONLY : SNDS= 57
LABELLING ONLY : ANDS= 54
LABELLING ONLY : SANDS= 50
LABELLING ONLY : DIN A= 147
LABEL STANDARD: DIN A= 36
LABEL STANDARD: DIN D= 40
LABEL STANDARD: DIN F= 33
ADMINISTRATIVE: ANDS = 34
ADMINISTRATIVE: NDS = 37
ADMINISTRATIVE: SNDS = 33
ADMINISTRATIVE: SANDS = 36
ADMINISTRATIVE: DIN A = 31
ADMINISTRATIVE: DIN D = 39
ADMINISTRATIVE: DIN F = 27
Biologics
NAS: NDS = 259
CLIN C&M: NDS = 293
CLIN C&M: SNDS = 284
CLIN C&M: DIN B = N/A
CLIN: NDS = N/A
CLIN: SNDS = 264
C&M ANDS = 178
C&M: SANDS = N/A
C&M: SNDS = 141
C&M: DINB = 210
COMP C&M: ANDS = N/A
COMP C&M: SNDS = 171
COMP C&M: DIN B = 206
LABELLING ONLY: NDS = 57
LABELLING ONLY: SNDS = 56
PUBLISHED DATA: SNDS = 193
ADMINISTRATIVE: NDS = 26
ADMINISTRATIVE: DINB = N/A
Other information
Review 1= Drug Submission Reviews
- Acronyms
NDS: New Drug Submission
SNDS: Supplement to a New Drug Submission
ANDS: Abbreviated New Drug Submission
SANDS: Supplement to an Abbreviated New Drug Submission
DIN: Drug Identification Number Application
DIN A=drug identification number application for a pharmaceutical
DIN B=drug identification number application for a biologic
DIN D=drug identification number application for a disinfectant
DIN F=drug identification number application for a Category IV
INDS: Investigation New Drug Submission
ESC: Experimental Studies Certificate
NAS: New Active Substance
OTC: Over the Counter
Rx: Prescription
CLIN: Clinical
COMP: Comparative Bio, Clinical or Pharmacodynamics Studies
C&M: Chemistry and Manufacturing
N/A: At the time of reporting, either no submissions of that type were received or no reviews of that submission type were completed, therefore no performance information is available.
- Performance
As per the User Fee Act (UFA), when, where a regulating authority's performance in a particular fiscal year in respect of a user fee does not meet the standards established by it for that fiscal year by a percentage greater than 10%, the UFA requires that the user fee be reduced by the percentage missed, up to a maximum of 50%. The reduced fees are in effect until the date of the next Departmental Results Report.
See Note 1
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 46,189,732 | 43,609,604 | 87,418,496 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 44,902,344 | 87,415,128 |
| 2018-19 | 45,800,391 | 89,024,719 |
| 2019-20 | 46,716,399 | 90,538,542 |
Medical Device License Application Fees
Fee name
Medical Device License Application Fees
Fee type
Regulatory (R)
Fee-setting authority
Financial Administrative Act
Year introduced
1998
Year last amended
2011
Performance standard
Review 1 (average time in calendar days)
Class II New = 15
Class III New = 60
Class III Near Patient =60
Class III Manufacturing Amendment = 60
Class III Significant Amendment = 60
Class IV New = 75
Class IV Human-Animal Tissue =75
Class IV Near Patient In Vitro Diagnostic Devices = 75
Class IV Manufacturing Amendment = 75
Class IV Significant Amendment = 75
Performance results
Review 1 (average time in calendar days)
Class II New = 12
Class III New = 59
Class III Near Patient = 57
Class III Manufacturing Amendment = 58
Class III Significant Amendment = 61
Class IV New = 74
Class IV Human-Animal Tissue= 76
Class IV Near Patient IVD = NA
Class IV Manufacturing Amendment = 46
Class IV Significant Amendment= 74
Other information
Performance
As per the User Fee Act (UFA), when, where a regulating authority's performance in a particular fiscal year in respect of a user fee does not meet the standards established by it for that fiscal year by a percentage greater than 10%, the UFA requires that the user fee be reduced by the percentage missed, up to a maximum of 50%. The reduced fees are in effect until the date of the next Departmental Performance Report.
Two Medical Device License Application fees lines did not meet the performance standard, but did not exceed the target by more than 10%, therefore there are no penalties incurred. They are:
- Class III Significant Amendment, with a target of 60 days, and a performance of 61 days.
- Class IV Human-Animal Tissue with a target of 75 days, and a performance of 76 days.
See Note 1
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 5,615,432 | 6,261,776 | 20,112,968 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 6,473,580 | 16,295,244 |
| 2018-19 | 6,603,052 | 16,595,441 |
| 2019-20 | 6,735,113 | 16,877,929 |
Fee for Right to Sell a Licensed Medical Device
Fee name
Fee for Right to Sell a Licensed Medical Device
Fee type
Regulatory (R)
Fee-setting authority
Financial Administrative Act
Year introduced
1999
Year last amended
2011
Performance standard
20 calendar days from deadline for receipt of annual notification to update the Medical Devices License Listing (MDALL) database
Performance results
99.1% within 20 calendar days
Other information
See Note 1
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 8,336,607 | 8,412,791 | 14,091,638 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 8,614,413 | 17,691,362 |
| 2018-19 | 8,786,701 | 18,010,286 |
| 2019-20 | 8,962,435 | 18,303,763 |
Medical Device Establishment Licensing Fees
Fee name
Medical Device Establishment Licensing Fees
Fee type
Regulatory (R)
Fee-setting authority
Financial Administrative Act
Year introduced
2000
Year last amended
2011
Performance standard
120 Calendar days to issue / renew license
Performance results
Average number of days: 20 days.
Other information
See Note 1
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 9,625,198 | 10,655,054 | 9,339,534 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 10,117,702 | 9,526,324 |
| 2018-19 | 10,320,056 | 9,716,851 |
| 2019-20 | 10,526,457 | 9,911,188 |
Veterinary Drug Evaluation Fees
Fee name
Veterinary Drug Evaluation Fees
Fee type
Regulatory (R)
Fee-setting authority
Financial Administrative Act
Year introduced
1996
Year last amended
N/A
Performance standard
Review 1 (average time in calendar days)
NDS (including Priority Review) = 300
ANDS = 300
SNDS = 240
SANDS = 240
Admin = 90
DIN (including changes to DINs) = 120
NC = 90
ESC = 60
Labels = 45 / N/A (No longer reviewed)
Emergency Drug Release = 2
Performance results
Review 1 (average time in calendar days)
NDS (including Priority Review) = 307
ANDS = 339
SNDS = 222
SANDS = 221
Admin = 41
DIN (including changes to DINs) = 102
NC = 80
ESC = 83
Labels = N/A
Emergency Drug Release = < 2
Other information
i. Acronyms
NDS: New Drug Submission
ANDS: Abbreviated New Drug Submission
SNDS: Supplement to a New Drug Submission
SANDS: Supplement to an Abbreviated New Drug Submission
ESC: Experimental Studies Certificate
NC: Notifiable Change
N/A: at time of reporting either no submissions of that type were received or no reviews of that submission type were completed, therefore no performance information available.
ii. Performance
Three Veterinary Drug Evaluation Fee fees lines did not meet the performance standard, but are not subject to the User Fees Act, therefore there are no penalties incurred. They are:
- New Drug Submission (including Priority Review) with a target of 300 days, and a performance of 307 days.
- Abbreviated New Drug Submission, with a target of 300 days and a performance of 339 days.
- Experimental Studies Certificate with a target of 60 days and a performance of 83 days.
See Note 1
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 914,000 | 833,874 | 5,673,729 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 914,000 | 5,766,989 |
| 2018-19 | 914,000 | 5,873,282 |
| 2019-20 | 914,000 | 5,973,355 |
Fees charged for filing a claim for exemption under the Hazardous Materials Information Review Act
Fee name
Fees charged for filing a claim for exemption under the Hazardous Materials Information Review Act
Fee type
Regulatory (R)
Fee-setting authority
Hazardous Materials Information Review Act, section 48 and Hazardous Materials Information Review Regulations, sections 4, 5, and 7.
Year introduced
1988
Year last amended
2002
Performance standard
95% of claims registered within 7 days of receipt of the complete application package.
Performance results
98% of claims were registered within 7 days of receipt of the complete application package.
Other information
Fees not subject to the User Fees Act (UFA) as fees have not been updated since the UFA came into force.
Financial Information, 2016-17 (dollars)
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 700,000 | 1,283,545.60 | 2,699,758.10 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 570,000 | 2,700,000 |
| 2018-19 | 570,000 | 2,700,000 |
| 2019-20 | 570,000 | 2,700,000 |
Pest Control Product Application Examination Service
Fee name
Pest Control Product Application Examination Service
Fee type
Regulatory (R)
Fee-setting authority
Pest Control Products Act (PCPA)
Year introduced
1997
Year last amended
N/A
Performance standard
The performance standard is 90% of applications are to be processed within the applicable review timelines.
Category A: Review timelines range from 285 to 655 days.
Category B: Review timelines range from 158 to 470 days.
Category C: Review timeline is 240 days.
Category D: Review timelines range from 10 to 247 days.
Category E: Review timelines range from 30 to 159 days.
Performance results
Category A = 84%
Category B = 90%
Category C = 99%
Category D = 95%
Category E = 55%
Other information
Fees not subject to User Fees Act as at March 31, 2017 (2016-17) but have since been updated effective April 1, 2017 (2017-18) and will therefore be subject to the Service Fees Act (SFA).
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 3,490,000 | 2,590,800 | 20,079,000 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 3,648,000 | 22,665,000 |
| 2018-19 | 3,732,000 | 22,957,000 |
| 2019-20 | 3,843,000 | 23,332,000 |
Right or Privilege to manufacture or sell a Pest Control Product in Canada and for Establishing a Maximum Residue Limit in relation to a Pest Control Product
Fee name
Right or Privilege to manufacture or sell a Pest Control Product in Canada and for Establishing a Maximum Residue Limit in relation to a Pest Control Product
Fee type
Regulatory (R)
Fee-setting authority
Financial Administration Act (FAA)
Year introduced
1997
Year last amended
N/A
Performance standard
100% of all fees for the right or privilege to manufacture or sell a pest control product in Canada are invoiced by April 30th of each fiscal year.
Performance results
100% of all invoices were issued by April 30, 2016.*
Other information
Fees not subject to User Fees Act as at March 31, 2017 (2016-17) but have since been updated effective April 1, 2017 (2017-18) and will therefore be subject to the Service Fees Act (SFA).
*Includes cases where a Notice of Extension is sent to the requester within 30 days of receipt of the request.
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 4,500,000 | 5,304,300 | 41,110,000 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 7,149,000 | 44,410,000 |
| 2018-19 | 7,312,000 | 44,984,000 |
| 2019-20 | 7,530,000 | 45,717,000 |
Fees for processing requests filed under the Access to Information Act
Fee name
Fees for processing requests filed under the Access to Information Act
Fee type
Other products and services
Fee-setting authority
Access to Information Act
Year introduced
1988
Year last amended
1992
Performance standard
A response is provided within 30 days following receipt of a request; the response time may be extended under section 9 of the Access to Information Act.
Performance results
Health Canada achieved a compliance rate* of 58.7% for fiscal 2016-17. Public Health Agency of Canada achieved a compliance rate of 88.5% for fiscal 2016-17.
Other information
The Act authorizes fees for certain aspects of processing formal requests and the fee structure is prescribed in the ATI Regulations. However, TBS in May 2016 issued the Interim Directive on the Administration of the Access to Information Act which imposed a requirement to waive all fees chargeable other than the $5 application fee, regardless of the size and scope of the request or burden on the Department to process. Based on requests received in 2016-2017, HC collected $5,720 in application fees and $728 in search fees for a total of $6,448, and PHAC collected $480 in application fees. HC waived $3,787 in fees and PHAC waived $380 in fees. These search fees were collected before the May 2016 TBS Interim Directive.
*Includes cases where a Notice of Extension is sent to the requester within 30 days of receipt of the request.
| Forecast revenue | Actual revenue | Full cost |
|---|---|---|
| 8,000 | 6,928* | 9,175,000 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 8,500* | 12,150,000 |
| 2018-19 | 8,500* | 12,150,000 |
| 2019-20 | 8,500* | 12,150,000 |
Note 1 - The forecasted revenues and estimated full costs are point estimates based on available data at the time of the preparation of these figures. Further, user fees related to drugs and medical devices are currently undergoing fee renewal review. As such, the actual revenues and full costs in the future may vary from these forecasts and estimates.
| Forecast revenue | Actual revenue | Full cost | |
|---|---|---|---|
| Regulatory subtotal | 107,691,557 | 107,733,067 | 277,637,530 |
| Other products and services subtotal | 8,000 | 6,928 | 9,175,000 |
| Total, all fee types | 107,699,557 | 107,739,995 | 286,812,530 |
| Planning year | Forecast revenue | Estimated full cost |
|---|---|---|
| 2017-18 | 112,157,665 | 302,032,154 |
| 2018-19 | 114,402,037 | 308,456,121 |
| 2019-20 | 116,768,339 | 315,308,813 |
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