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Difference between DSUR, IND Annual Report, and ASR

1. Abbreviation Stands for

IND-AR Investigational New Drug – Annual Report

DSUR Developmental Safety Update report

ASR Annual Summary Report

2. Geography

IND-AR - United States

DSUR - Global (ICH)

ASR - EU/EEA Specific

3. Duration 

IND-AR Annual

DSUR Cumulative Data

ASR Annual

4. Reference

IND-AR 21 CFR 312.33


ASR EU Directive 2001/20/EC

5. Fatal Reports - Listings

IND-AR Required

DSUR Required

ASR Not Required

6. Data Lock Points

IND-AR IND Anniversary Date

DSUR Developmental International Birth Date (D-IBD)

ASR Developmental International Birth Date (D-IBD)

7. Non Serious AE Summaries

IND-AR Required

DSUR Not Required

ASR Not Required

8. Investigator's Brochure

IND-AR Required

DSUR Not Required

ASR Required

9. Scope

IND-AR Indication

DSUR Molecule

ASR Molecule

10. Summary of Important Risks

IND-AR Not required

DSUR Required

ASR Required

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