Table 2

Characteristics of the 203 clinical information packages released between March 2019 and March 2022

Number of packages
Total clinical information packages203
By product type
 Small molecule drug137 (67%)
 Biologic44 (22%)
 Vaccine20 (10%)
 Radiopharmaceutical2 (1%)
By decision date
 Before 200321
By submission type
 New applications (NDS, NDS-NAS)137
 Supplemental applications (SNDS, SNDS-c)54
 Generic drug applications (ANDS)2
 Interim order10
By authorisation type
 Authorised with conditions10
  • 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.