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

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.

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:

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
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