The Drug Submission Review Performance Reports provide detailed metrics about the timeliness of the pre-market drug review process against performance service standards. The quarterly report compares five consecutive quarters from January-March 2020 to January-March 2021. The annual report compares five consecutive fiscal years from 2016-2017 to 2020-2021. The reports are broken down by operational areas. The Therapeutic Product Directorate (TPD) report summarises performance metrics for pharmaceuticals. The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) 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.
Quarterly Reports important highlights:
NNHPD:
- There was a significant increase in the volume of Drug Identification Number Applications for Disinfectant products (DIND) received.
- There was a 55% decrease in the number of DINA submissions received in Q2 2020-2021 (26) compared to Q1 2020-2021 (58), a 96% increase when comparing Q3 2020-2021 (51) to Q2 2020-2021 and a 47% decrease when comparing Q4 2020-2021 (27) to Q2 2020-2021.
- There was a 3% increase in the number of DINF submissions received in Q2 2020-2021 (80) compared to Q1 2020-2021 (78), a 50% decrease when comparing Q3 2020-2021 (40) to Q2 2020-2021 and a 22.5% decrease when comparing Q4 2020-2021 (31) to Q3 2020-2021.
Annual Reports Important Highlights:
- A performance standard of 99.99% was achieved for DIN-D submissions with 1/214 submissions completed after the target date. A performance standard of 98% was achieved for DINA submissions with 1/75 submissions cleared after the target date. A performance target of 80% was achieved for ANDS submissions with 1/5 submission completed after the target date.
- NDED achieved a performance standard of 99.99% for cost recovered submissions with 3/876 submissions completed after the target dates.
- A performance standard of 81% was achieved for disinfectant related PDC submissions with 23/120 submissions completed after the target date and a performance standard of 98% was achieved for OTC s.
- NDED achieved a performance standard of 99.95% was achieved for non-cost recovered submissions with 28/535 submissions completed after the target date.
