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 for TPD and BGTD compares five consecutive fiscal years (April 1 - March 31), and the annual report for NNHPD compares three 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) report summarises performance metrics for pharmaceuticals. The Biologics and Genetic Therapies Directorate (BGTD) report summarises performance metrics for biologics. 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

TPD:

  • A revised version of the TPD Annual Drug Submission Performance report for Fiscal Year 2016-2017 is available. To obtain a full electronic copy please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the TPD Annual Drug Submission Performance report for Fiscal Year 2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the TPD Annual Drug Submission Performance report for Fiscal Year 2015-2016 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the TPD Annual Drug Submission Performance report for Fiscal Year 2014-2015 please contact publications@hc-sc.gc.ca.

BGTD:

  • To obtain a full electronic copy of the BGTD Annual Drug Submission Performance report for Fiscal Year 2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the BGTD Annual Drug Submission Performance report for Fiscal Year 2015-2016 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the BGTD Annual Drug Submission Performance report for Fiscal Year 2014-2015 please contact publications@hc-sc.gc.ca.

NNHPD:

  • To obtain a full electronic copy of the NNHPD Annual Drug Submission Performance report for Fiscal Year 2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the NNHPD Annual Drug Submission Performance report for Fiscal Year 2015-2016 please contact publications@hc-sc.gc.ca.

Quarterly Reports

TPD:

  • To obtain a full electronic copy of the TPD Quarterly Drug Submission Performance report for Q3-2017-2018 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the TPD Quarterly Drug Submission Performance report for Q2-2017-2018 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the TPD Quarterly Drug Submission Performance report for Q1-2017-2018 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the TPD Quarterly Drug Submission Performance report for Q4-2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the TPD Quarterly Drug Submission Performance report for Q3-2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the TPD Quarterly Drug Submission Performance report for Q2-2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the TPD Quarterly Drug Submission Performance report for Q1-2016-2017 please contact publications@hc-sc.gc.ca.

BGTD:

  • To obtain a full electronic copy of the BGTD Quarterly Drug Submission Performance report for Q3-2017-2018 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the BGTD Quarterly Drug Submission Performance report for Q2-2017-2018 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the BGTD Quarterly Drug Submission Performance report for Q1-2017-2018 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the BGTD Quarterly Drug Submission Performance report for Q4-2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the BGTD Quarterly Drug Submission Performance report for Q3-2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the BGTD Quarterly Drug Submission Performance report for Q2-2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the BGTD Quarterly Drug Submission Performance report for Q1-2016-2017 please contact publications@hc-sc.gc.ca.

NNHPD:

  • To obtain a full electronic copy of the NNHPD Quarterly Drug Submission Performance report for Q3-2017-2018 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the NNHPD Quarterly Drug Submission Performance report for Q2-2017-2018 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the NNHPD Quarterly Drug Submission Performance report for Q1-2017-2018 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the NNHPD Quarterly Drug Submission Performance report for Q4-2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the NNHPD Quarterly Drug Submission Performance report for Q3-2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the NNHPD Quarterly Drug Submission Performance report for Q2-2016-2017 please contact publications@hc-sc.gc.ca.
  • To obtain a full electronic copy of the NNHPD Quarterly Drug Submission Performance report for Q1-2016-2017 please contact publications@hc-sc.gc.ca.

Reports

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