Service standards for drug submission evaluations (pharmaceuticals and biologic products) under 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 in calendar days in the below-noted tables.

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 2021 to 2022:

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 2021-22, HPFB's actual results for these submissions were:

Departmental contacts

To make any general inquiries on the Licencing program for pharmaceutical drugs please contact:

Pharmaceutical Drugs Directorate
Health Products and Food Branch
1600 Scott Street
Address Locator: 3106B
Ottawa, Ontario
K1A 0K9
E-mail: pharma_drug_enquiries-renseignements_medicaments_pharma@hc-sc.gc.ca
Telephone: 613-957-0368
Fax: 613-952-7756

To make any general inquiries on the Licencing program for biologic products please contact:

Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Building 6, Address Locator: 0601B
100 Eglantine Driveway
Tunney's Pasture
Ottawa, Ontario
K1A 0K9
E-mail: hc.brdd.dgo.enquiries.sc@hc-sc.gc.ca
Telephone: 613-863-8405

To make any general inquiries on Cost Recovery, please contact:

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