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 average time in calendar days in the below-noted tables.

Service Delivery Standards
Pharmaceuticals Average Time in Calendar Days
New Active Substance: NDS 300
Clinical/Chemistry & Manufacturing: NDS 300
Clinical/Chemistry & Manufacturing: SNDS 300
Clinical/Chemistry & Manufacturing: DIN-A 210
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
Comparative Studies/Chemistry & Manufacturing: DIN-A 210
Chemistry & Manufacturing: ANDS 180
Chemistry & Manufacturing: SANDS 180
Chemistry & Manufacturing: NDS 180
Chemistry & Manufacturing: SNDS 180
Chemistry & Manufacturing: DIN-A 210
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
Service Delivery Standards
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%
Service Delivery Standards
Biologics Average Time in 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
Service Delivery Standards
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 2019 to 2020:

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 2019-2020, HPFB's actual results for these submissions were:

Performance
Pharmaceuticals Average Time in Calendar Days
New Active Substance: NDS 267
Clinical/Chemistry & Manufacturing: NDS 276
Clinical/Chemistry & Manufacturing: SNDS 300
Clinical/Chemistry & Manufacturing: DIN-A 207
Clinical Only: NDS N/A
Clinical Only: SNDS 252
Clinical Only: DIN-A N/A
Comparative Studies/Chemistry & Manufacturing: ANDS 168
Comparative Studies/Chemistry & Manufacturing: NDS N/A
Comparative Studies/Chemistry & Manufacturing: SANDS 161
Comparative Studies/Chemistry & Manufacturing: SNDS 176
Comparative Studies/Chemistry & Manufacturing: DIN-A N/A
Chemistry & Manufacturing: ANDS 170
Chemistry & Manufacturing: NDS N/A
Chemistry & Manufacturing: SANDS 147
Chemistry & Manufacturing: SNDS 158
Chemistry & Manufacturing: DIN-A 183
Published Data: SNDS 282
Published Data: SANDS N/A
Published Data: DIN-A N/A
Switch from Prescription to Over-the-Counter: NDS N/A
Switch from Prescription to Over-the-Counter: SNDS N/A
Disinfectant: NDS-D 300
Disinfectant: SNDS-D N/A
Disinfectant: DIN-D (Non-Clinical/Clinical Only) 204
Disinfectant: DIN-D (Labelling Only) 146
Labelling Only: NDS 54
Labelling Only: SNDS 50
Labelling Only: ANDS 39
Labelling Only: SANDS 38
Labelling Only: DIN-A 153
Labelling Standard: DIN-A 40
Labelling Standard: DIN-D 38
Labelling Standard: DIN-F 36
Administrative: ANDS 22
Administrative: NDS 29
Administrative: SNDS 17
Administrative: SANDS 17
Administrative: DIN-A 31
Administrative: DIN-D 32
Administrative: DIN-F 38
Pharmaceuticals Percentage Within Target
Notifiable Change Submissions (Safety 90) TPD/ NNHPD 100% / 100%
Notifiable Change Submissions (Safety 120) TPD/ NNHPD 96% / n/a
Notifiable Change Submissions - Administrative (45 day) 100%
7 day Clinical Trial Applications (CTA) and Amendments (CTA-A) - Phase I (bioequivalence; healthy human) 45% for CTA
69% 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
Performance
Biologics Average Time in Calendar Days
New Active Substance: NDS 281
Clinical/Chemistry & Manufacturing: NDS 268
Clinical/Chemistry & Manufacturing: SNDS 268
Clinical/Chemistry & Manufacturing: DIN-B 209
Clinical Only: SNDS 259
Chemistry & Manufacturing: ANDS 178
Chemistry & Manufacturing: SANDS N/A
Chemistry & Manufacturing: SNDS 153
Chemistry & Manufacturing: DIN-B N/A
Comparative Studies/Chemistry & Manufacturing: ANDS N/A
Comparative Studies/Chemistry & Manufacturing: SNDS 179
Comparative Studies/Chemistry & Manufacturing: DIN-B N/A
Labelling Only: NDS 59
Labelling Only: SNDS 55
Labelling Only: DIN-B N/A
Published Data: SNDS 279
Administrative: NDS 44
Administrative: DIN-B 43
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:  hr.cro-brc.sc@canada.ca
Telephone: 613-617-7323
Fax: 613-954-9981

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