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 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 Time in Calendar Days
New Active Substance: For drugs under Division 8 of the Food and Drug Regulations 300
Clinical/Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations 210
Clinical/Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 300
Clinical Only: For drugs under Division 1 of the Food and Drug Regulations 210
Clinical Only: For drugs under Division 8 of the Food and Drug Regulations 300
Comparative Studies/Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations 210
Comparative Studies/Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 180
Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations 210
Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 180
Clinical or non-clinical data only, in support of safety updates to the labelling 120
Disinfectant: For drugs under Division 1 of the Food and Drug Regulations 210
Disinfectant: For drugs under Division 8 of the Food and Drug Regulations 300
Labelling Only: For drugs under Division 1 of the Food and Drug Regulations 120
Labelling Only: For drugs under Division 8 of the Food and Drug Regulations 120
Labelling Only (Generic Drugs): For drugs under Division 8 of the Food and Drug Regulations 120
Labelling Only (Disinfectants) 90
Labelling Standard: 60
Administrative 45
Service Delivery Standards
Pharmaceuticals Time in Calendar Days
Notifiable Change Submissions (Safety 90) 90
Notifiable Change Submissions (Safety 120) 120
Notifiable Change Submissions - Administrative 45
Clinical Trial Applications and Amendments - Phase I (bioequivalence; healthy human) 7
Clinical Trial Applications and Amendments - Phase I (all other), Phase II, and Phase III 30
Service Delivery Standards
Biologics Time in Calendar Days
New Active Substance: For drugs under Division 8 of the Food and Drug Regulations 300
Clinical/Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations 210
Clinical/Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 300
Clinical Only: For drugs under Division 1 of the Food and Drug Regulations 210
Clinical Only: For drugs under Division 8 of the Food and Drug Regulations 300
Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations 210
Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 180
Comparative Studies/Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations 210
Comparative Studies/Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 180
Clinical or non-clinical data only, in support of safety updates to the labelling 120
Labelling Only: For drugs under Division 8 of the Food and Drug Regulations 120
Administrative 45
Service Delivery Standards
Biologics Time in Calendar Days
Notifiable Change Submissions (Quality 90) 90
Notifiable Change Submissions (Safety 90) 90
Notifiable Change Submissions (Safety 120) 120
Notifiable Change - Administrative 45
Clinical Trial Applications and Amendments 30

Performance Target:

The targets for achieving these standards are as follow:

For drugs under Division 1 & 8 of the Food and Drug Regulations: The targets for achieving these standards are set at 100% of submissions meeting the performance standard to reach first decision within the applicable fee categories as indicated 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 meeting the performance standard for Notifiable Change Submissions & Clinical Trial Applications/Amendments (7 day) and at 100% of submissions meeting the performance standard for Clinical Trial Applications / Amendments (30 day) (also indicated in the above tables).

Performance result in fiscal year 2020 to 2021:

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 2020-2021, HPFB's actual results for these submissions were:

Performance
Pharmaceuticals Performance Results
New Active Substance: For drugs under Division 8 of the Food and Drug Regulations 100%
Clinical/Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations N/A
Clinical/Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 100%
Clinical Only: For drugs under Division 1 of the Food and Drug Regulations N/A
Clinical Only: For drugs under Division 8 of the Food and Drug Regulations 100%
Comparative Studies/Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations 100%
Comparative Studies/Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 100%
Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations 100%
Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 100%
Clinical or non-clinical data only, in support of safety updates to the labelling 100%
Disinfectant: For drugs under Division 1 of the Food and Drug Regulations 100%
Disinfectant: For drugs under Division 8 of the Food and Drug Regulations N/A
Labelling Only: For drugs under Division 1 of the Food and Drug Regulations 100%
Labelling Only: For drugs under Division 8 of the Food and Drug Regulations 100%
Labelling Only (Generic Drugs): For drugs under Division 8 of the Food and Drug Regulations 100%
Labelling Only (Disinfectants) 100%
Labelling Standard 100%
Administrative 99.6%
Pharmaceuticals Performance Results
Notifiable Change Submissions (Safety 90) TPD/ NNHPD 99% / 100%
Notifiable Change Submissions (Safety 120) TPD/ NNHPD 100% / n/a
Notifiable Change Submissions - Administrative (45 day) 50%
7 day Clinical Trial Applications (CTA) and Amendments (CTA-A) - Phase I (bioequivalence; healthy human) 41% for CTA
57% 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 Performance Results
New Active Substance: For drugs under Division 8 of the Food and Drug Regulations 100%
Clinical/Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations N/A
Clinical/Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 100%
Clinical Only: For drugs under Division 1 of the Food and Drug Regulations N/A
Clinical Only: For drugs under Division 8 of the Food and Drug Regulations 100%
Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations 100%
Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations 100%
Comparative Studies/Chemistry & Manufacturing: For drugs under Division 1 of the Food and Drug Regulations N/A
Comparative Studies/Chemistry & Manufacturing: For drugs under Division 8 of the Food and Drug Regulations N/A
Clinical or non-clinical data only, in support of safety updates to the labelling 100%
Labelling Only: For drugs under Division 8 of the Food and Drug Regulations 100%
Administrative 100%
Biologics Performance Results
Notifiable Change Submissions (Quality 90) 99.4%
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
100% for CTA-A

Departmental Contacts

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

On Cost Recovery:
E-mail: cro-brc@hc-sc.gc.ca
Telephone: 613-617-7323
Fax: 613-954-9981

Page details

Date modified: