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Table. 5.

Table. 5.

Surveyed companies’ opinions on DSUR procedure and operation.

Response Domestic N (%) Global N (%)
• In the year of initial introduction of the DSUR submission, which phase of clinical trials do you think should be applied to DSUR submission? (Multiple answers allowed)
Initial IND (n=12, 85.8%) 5 (35.7) 7 (50)
End of Phase 1 (n=0, 0%) 0 (0) 0 (0)
End of Phase 2 (n=0, 0%) 0 (0) 0 (0)
End of Phase 3 (n=1, 7.1%) 1 (7.1) 0 (0)
Others (n=1, 7.1%) 1 (7.1) 0 (0)
• Which do you think is the appropriate time for Last DSUR submission?
Declaration date of end of a clinical trial (n=7, 53.8%) 2 (15.4) 5 (38.5)
Submit date of NDA (n=3, 23.1%) 2 (15.4) 1 (7.7)
Others (n=3, 23.1%) 2 (15.4) 1 (7.7)
• According to DSUR guideline, pharmaceutical company should submit both PBRER and DSUR when it conducts clinical trials on licensed drugs. Please select your preferred post-marketing safety reporting method for investigational product.
PBRER Only (n=7, 53.8%) 2 (15.4) 5 (38.5)
PBRER and DSUR (n=3, 23.1%) 1 (7.7) 2 (15.4)
PBRER and (if necessary) DSUR (n=3, 23.1%) 3 (23.1) 0 (0)
• How long do you think a grace period is needed after the introduction of the mandatory submission of DSUR for investigational product?
6 Months (n=2, 15.4%) 2 (15.4) 0 (0)
1 Year (n=5, 38.5%) 2 (15.4) 3 (23.1)
2 Years (n=1, 7.7%) 0 (0) 1 (7.7)
3 Years (n=3, 23.1%) 1 (7.7) 2 (15.4)
Others (n=1, 7.7%) 1 (7.7) 1 (7.7)
Korean J Clin Pharm 2021;31:53-60 https://doi.org/10.24304/kjcp.2021.31.1.53
© 2021 Korean J Clin Pharm