Number of packages | |
Total clinical information packages | 203 |
By product type | |
Small molecule drug | 137 (67%) |
Biologic | 44 (22%) |
Vaccine | 20 (10%) |
Radiopharmaceutical | 2 (1%) |
By decision date | |
Before 2003 | 21 |
2003–2018 | 49 |
2019–present | 133 |
By submission type | |
New applications (NDS, NDS-NAS) | 137 |
Supplemental applications (SNDS, SNDS-c) | 54 |
Generic drug applications (ANDS) | 2 |
Interim order | 10 |
By authorisation type | |
NOC | 191 |
Authorised with conditions | 10 |
NOD-W | 2 |
ANDS, abbreviated new drug submission; NDS, new drug submission; NDS-NAS, new drug submission-new active substance; NOC, notice of compliance; NOD-W, notice of deficiency-withdrawal; SNDS, supplement to a new drug submission; SNDS-c, supplement to a new drug submission containing confirmatory trials.