Fees for Human Drug Regulatory Activities in Canada

1. Overview

Health Canada charges fees for regulatory activities related to human drugs, including prescription and non-prescription pharmaceuticals, biologics, disinfectants, and sanitizers with disinfectant claims. These fees support the assessment of safety, efficacy, and quality before authorization for sale, as well as post-market surveillance and compliance. Fees are governed by the Fees in Respect of Drugs and Medical Devices Order and Licensed Dealers for Controlled Drugs and Narcotics Fees Regulations. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html

2. Fee to Evaluate Human Drug Submissions

This fee is charged before a drug is authorized for sale. Health Canada assesses the safety, efficacy, and quality of submissions and applications. Guidance on management of drug submissions and applications, as well as disinfectant drugs applications, is available. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html

Related Links

• Fees for the review of drug submissions and applications: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees/fees-review-drug-submissions-applications.html
• Human drug submission/application review fees: https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/pharmaceutical-submission-application-review-funding-fees-drugs-health-products.html
• Management of drug submissions and applications guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html
• Management of disinfectant drug applications guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/management-disinfectant-drug-applications-2019/document.html

3. Master File Fees

Master files contain confidential information on manufacturing, processing, or packaging processes and components. They protect confidential business information under the Access to Information Act and Food and Drugs Act. These are useful when information is not available to dosage form manufacturers or sponsors of drug submissions, DIN applications, or clinical trial applications (CTAs). Procedures and administrative requirements for master files are outlined in guidance. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html

Related Links

• Guidance on master files procedures and administrative requirements: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/master-files-procedures-administrative-requirements.html
• Fees for master files for human drugs: https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/fees-master-files-human-drugs.html

4. Fee to Examine an Application for an Establishment Licence

This fee applies to facility inspections evaluating compliance with regulatory requirements for the production, importation, testing, and distribution of drugs. Guidance on drug establishment licences, application forms, and management of applications and performance is provided. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html

Related Links

• Drug establishment licensing fees: https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/drug-establishment-licence-funding-fees-drugs-health-products.html
• Guidance on fees for review of human and veterinary drug establishment licence applications: https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/review-drug-establishment-licence.html
• Guidance on drug establishment licences and drug establishment licensing fees (GUI-0002): https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002.html
• Drug establishment licence application: instructions (FRM-0033): https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/drug-establishment-licence-application-0033.html
• Management of applications and performance for drug establishment licences (GUI-0127): https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/management-applications-performance-drug-establishment-licences-0127/document.html

5. Fee for the Right to Sell Drugs

This is an annual fee paid by industry for the right to sell and maintain human drugs on the Canadian market. It supports post-market surveillance and compliance and enforcement activities. Guidance on fees for the right to sell drugs and an information sheet on management of drug company contact and financial account information are available. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html

Related Links

• Fees for the right to sell drugs: https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/right-sell-drugs-funding-fees-drugs-health-products.html
• Guidance on fees for the right to sell drugs: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees/right-to-sell-drugs-2019/document.html
• Information sheet: Management of drug company contact and financial account information: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees/information-sheet-management-drug-company-contact-financial-account-information.html

6. Additional Information

• How fees are set: Based on the Fees in Respect of Drugs and Medical Devices Order and Licensed Dealers for Controlled Drugs and Narcotics Fees Regulations.
• Payment of invoices: General guidance on how to pay fees is available.
• Related fees: Certificates of supplementary protection (CSP) fees.
• Broader resources: Guidance documents on applications and submissions, forms, and establishment licences overview.
• Page update: Last updated June 17, 2024. Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html