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Drug Products

Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.

What information can you find here?

This section contains links to reports and publications related to drug products.

Drug Submission Performance Reports

The Drug Submission Review Performance Reports provide detailed metrics about the timeliness of pre-market drug review process against performance service standards. The annual report compares five consecutive fiscal years (April 1 - March 31), while the quarterly report compares five quarters. The reports are broken down by operational areas. The Therapeutic Product Directorate (TPD) was renamed to the Pharmaceutical Drugs Directorate (PDD). The PDD report summarises performance metrics for pharmaceuticals. The Biologics and Genetic Therapies Directorate (BGTD) was renamed to the Biologic and Radiopharmaceutical Drugs Directorate (BRDD). The BRDD report summarises performance metrics for biologics and radiopharmaceutical drugs. The Natural and Non-Prescription Health Products Directorate (NNHPD) report summarises performance metrics for non-prescription (over-the-counter) and disinfectant drugs. Within each report, statistics are provided by submission type and show the number received, the number in workload, the number of decisions and the number of approvals and time to approval.

Submissions Received are counts of submissions received during the year using the filing date. Workload is reported as the number of submissions "under active review" on a given day. "Backlog" is the proportion of the workload that is over target. "Approvals" are Notice of Compliances (NOC) issued or issuable; an issuable NOC arises when a submission NOC is placed "on hold" awaiting authorization to market, due to requirements in the Patented Medicines (Notice of Compliance) Regulations, or due to a conversion of status from prescription to Over the Counter.

Drug Submission Performance Reports are available by request only. Please see contact information below.

Annual Reports

PDD:

BRDD:

NNHPD:

Quarterly Reports

PDD:

BRDD:

NNHPD:

Reports

  • Statistical Report 2023/2024 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection and Certificates of Supplementary Protection (To obtain a full electronic copy of this report, please contact publications-publications@hc-sc.gc.ca). [2024-08-13]
  • Statistical Report 2022/2023 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection and Certificates of Supplementary Protection (To obtain a full electronic copy of this report, please contact publications-publications@hc-sc.gc.ca). [2023-06-23]
  • Statistical Report 2021/2022 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection and Certificates of Supplementary Protection (To obtain a full electronic copy of this report, please contact publications-publications@hc-sc.gc.ca.) [2022-07-29]
  • Statistical Report 2020/2021 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection and Certificates of Supplementary Protection (To obtain a full electronic copy of this report, please contact publications-publications@hc-sc.gc.ca.) [2021-11-10]
  • Statistical Report 2019/2020 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection and Certificates of Supplementary Protection (To obtain a full electronic copy of this report, please contact publications-publications@hc-sc.gc.ca.) [2020-09-02]
  • Statistical Report 2018/2019 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection and Certificates of Supplementary Protection (To obtain a full electronic copy of this report, please contact publications-publications@hc-sc.gc.ca.) [2019-06-28]
  • Stakeholder Workshop on a National Buprenorphine Program [2004-12-06]

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