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Category designation by sponsors and Drug Regulatory Agencies for Carcinogenicity Assessment Documents (adapted from (ICH, 2016)).
| Categories | Sponsor | DRAs |
|---|---|---|
| Category 1 | 2 | 1 |
| Category 2 | 7 | 15 |
| Category 3a | 8 | 5 |
| Category 3b | 8 | 1 |
| Partial DRA alignment | 0 | 3 |
