Service Standards for Drug Submission Evaluations (Pharmaceuticals and Biologic Products) under the Food and Drug Regulations - Health Canada

Disclaimer: Information on this webpage is provided for illustrative purposes only. The Food and Drug Regulations should be relied upon for specific requirements, including if there are discrepancies between this page and the Food and Drug Regulations.

Service Description:

Health Canada posts service standards and performance information for regulatory services with over 100 regulatory authorizations, such as permits or licences, issued each year (high-volume regulatory transactions).

The evaluation of drug submissions is a service with a high volume of regulatory transactions used by drug manufacturers for all human drugs imported or sold in Canada.

Before a drug is authorized for sale in Canada, scientific evidence of its safety, efficacy and quality, as required by the Food and Drugs Act and regulations, must be provided for review by Health Canada to determine whether the benefits associated with the product outweigh the risks.

The Management of Drug Submissions and Applications (MDSG) guidance document is meant to assist drug manufacturers (sponsors) with applying for Drug Submission Evaluations and is a document that outlines the way in which Health Canada manages information and material submitted by sponsors in accordance with the Food and Drugs Act and the Food and Drug Regulations.

Service Standard:

The Health Products and Food Branch (HPFB) commits to service delivery standards to reach a first decision outlined as time in average calendar days in the below-noted tables.

Pharmaceuticals
Pharmaceuticals Time in Average Calendar Days
New Active Substance: NDS 300
Clinical/Chemistry & Manufacturing: NDS 300
Clinical/Chemistry & Manufacturing: SNDS 300
Clinical Only: NDS 300
Clinical Only: SNDS 300
Clinical Only: DIN-A 210
Comparative Studies/Chemistry & Manufacturing: ANDS 180
Comparative Studies/Chemistry & Manufacturing: NDS 180
Comparative Studies/Chemistry & Manufacturing: SANDS 180
Comparative Studies/Chemistry & Manufacturing: SNDS 180
Chemistry & Manufacturing: ANDS 180
Chemistry & Manufacturing: SANDS 180
Chemistry & Manufacturing: NDS 180
Chemistry & Manufacturing: SNDS 180
Published Data: SNDS 300
Published Data: SANDS 300
Published Data: DIN-A 210
Switch from Prescription to Over-the-Counter (No New Indication): NDS 180
Switch from Prescription to Over-the-Counter (No New Indication): SNDS 180
Disinfectant: NDS-D 300
Disinfectant: SNDS-D 300
Disinfectant: DIN-D (Non-Clinical/Clinical Only) 210
Disinfectant: DIN-D (Labelling Only) 180
Labelling Only: NDS 60
Labelling Only: SNDS 60
Labelling Only: ANDS 60
Labelling Only: SANDS 60
Labelling Only: DIN-A 180
Labelling Standard: DIN-A 45
Labelling Standard: DIN-D 45
Labelling 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
Pharmaceuticals
Pharmaceuticals Time in Calendar Days Performance Standard
Notifiable Change Submissions (Safety 90) 90 90% within time shown
Notifiable Change Submissions (Safety 120) 120
Notifiable Change Submissions - Administrative 45
Clinical Trial Applications and Amendments - Phase I (bioequivalence; healthy human) 7 100%
Clincial Trial Applications and Amendments - Phase I (all other), Phase II, and Phase III 30 100%
Biologics
Biologics Time in Average Calendar Days
New Active Substance: NDS 300
Clinical/Chemistry & Manufacturing: NDS 300
Clinical/Chemistry & Manufacturing: SNDS 300
Clinical Only: NDS 300
Clinical Only: SNDS 300
Chemistry & Manufacturing: ANDS 180
Chemistry & Manufacturing: SANDS 180
Chemistry & Manufacturing: SNDS 180
Chemistry & Manufacturing: DIN-B 210
Comparative Studies/Chemistry & Manufacturing: ANDS 180
Comparative Studies/Chemistry & Manufacturing: SNDS 180
Comparative Studies/Chemistry & Manufacturing: DIN-B 210
Labelling Only: NDS 60
Labelling Only: SNDS 60
Labelling Only: DIN-B 60
Published Data: SNDS 300
Administrative: NDS 45
Administrative: DIN-B 45
Biologics
Biologics Time in Calendar Days Performance Standard
Notifiable Change Submissions (Quality 90) 90 90% within time shown
Notifiable Change Submissions (Safety 90) 90
Notifiable Change Submissions (Safety 120) 120
Notifiable Change - Administrative 45
Clinical Trial Applications and Amendments 30 100%

Performance Target:

The targets for achieving these standards are as follow:

For NDS, SNDS, ANDS, SANDS, and DIN submissions: The targets for the average time to reach first decision on a submission within an individual fee line are displayed in the above tables.

For Notifiable Change submissions and Clinical Trial Applications and Amendments: The targets for achieving these standards are set at 90% of submissions within the applicable review timelines for Notifiable Change Submissions and at 100% for Clinical Trial Applications and Amendments (also indicated in the above tables).

Performance result in fiscal year 2018 to 2019:

Annual service performance is measured over the course of the fiscal year (April 1 - March 31). Performance results for a given fiscal year are published in the Report on Fees, which is normally tabled in Parliament and published in the third quarter (October-December) of the following fiscal year.

In 2018-2019, HPFB's actual results for these submissions were:

Pharmaceuticals
Pharmaceuticals Time in average Calendar Days
New Active Substance: NDS 254
Clinical/Chemistry & Manufacturing: NDS 278
Clinical/Chemistry & Manufacturing: SNDS 270
Clinical/Chemistry & Manufacturing: DIN-A 206
Clinical Only: NDS N/A
Clinical Only: SNDS 276
Clinical Only: DIN-A 208
Comparative Studies/Chemistry & Manufacturing: ANDS 168
Comparative Studies/Chemistry & Manufacturing: NDS 178
Comparative Studies/Chemistry & Manufacturing: SANDS 148
Comparative Studies/Chemistry & Manufacturing: SNDS 173
Comparative Studies/Chemistry & Manufacturing: DIN-A 202
Chemistry & Manufacturing: ANDS 170
Chemistry & Manufacturing: NDS 178
Chemistry & Manufacturing: SANDS 155
Chemistry & Manufacturing: SNDS 162
Chemistry & Manufacturing: DIN-A 194
Published Data: SNDS 271
Published Data: SANDS N/A
Published Data: DIN-A 189
Switch from Prescription to Over-the-Counter: NDS N/A
Switch from Prescription to Over-the-Counter: SNDS 179
Disinfectant: NDS-D 294
Disinfectant: SNDS-D N/A
Disinfectant: DIN-D (Non-Clinical/Clinical Only) 204
Disinfectant: DIN-D (Labelling Only) N/A
Labelling Only: NDS 50
Labelling Only: SNDS 52
Labelling Only: ANDS 40
Labelling Only: SANDS 37
Labelling Only: DIN-A 159
Labelling Standard: DIN-A 41
Labelling Standard: DIN-D 40
Labelling Standard: DIN-F 41
Administrative: ANDS 30
Administrative: NDS 28
Administrative: SNDS 24
Administrative: SANDS 26
Administrative: DIN-A 25
Administrative: DIN-D 34
Administrative: DIN-F N/A
Pharmaceuticals Percentage Within Target
Notifiable Change Submissions (Safety 90) TPD/ NNHPD 94% / 100%
Notifiable Change Submissions (Safety 120) TPD/ NNHPD 94% / n/a
Notifiable Change Submissions - Administrative (45 day) 100%
7 day Clinical Trial Applications (CTA) and Amendments (CTA-A) - Phase I (bioequivalence; healthy human) 75% for CTA
71% for CTA-A
30 day Clinical Trial Applications and Amendments - Phase I (all other), Phase II, and Phase III 100% for CTA
100% for CTA-A
Biologics
Biologics Time in Average Calendar Days
New Active Substance: NDS 226
Clinical/Chemistry & Manufacturing: NDS 275
Clinical/Chemistry & Manufacturing: SNDS 300
Clinical/Chemistry & Manufacturing: DIN-B N/A
Clinical Only: SNDS 275
Chemistry & Manufacturing: ANDS N/A
Chemistry & Manufacturing: SANDS N/A
Chemistry & Manufacturing: SNDS 143
Chemistry & Manufacturing: DIN-B 207
Comparative Studies/Chemistry & Manufacturing: ANDS N/A
Comparative Studies/Chemistry & Manufacturing: SNDS 179
Labelling Only: NDS 59
Labelling Only: SNDS 58
Labelling Only: DIN-B 105
Published Data: SNDS 273
Administrative: NDS N/A
Administrative: DIN-B 40
Biologics Percentage Within Target
Notifiable Change Submissions (Quality 90) 100%
Notifiable Change Submissions (Safety 90) 100%
Notifiable Change Submissions (Safety 120) 100%
Notifiable Change Submissions - Administrative (45 day) 100%
Clinical Trial Applications and Amendments (30 day) 100% for CTA
99.5% for CTA-A

Departmental Contacts

Please contact the Licensing Program to make any general inquiries or comments:

Office of Submissions and Intellectual Property (OSIP)
Resource Management and Operations Directorate
Health Canada
Finance Building, 2nd Floor
Tunney's Pasture
Address Locator: 0201A1
Ottawa, Ontario K1A 0K9
E-mail: hc.annual-annuelle.sc@canada.ca
Telephone: 613-946-1151
Fax: 613-954-3067

On Cost Recovery:
E-mail: hc.cost.recovery.sc@canada.ca
Telephone: 613-941-7283
Fax: 613-941-0285

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