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Table 1 Approval types and registries used for post-marketing regulatory purposes for orphan (non-oncology) drugs from 2000 to 2019. (data from the EU PAS register [14], European public assessment reports (EPARs) [13, 15] or publicly available information)

From: Registries for orphan drugs: generating evidence or marketing tools?

Approval type

Subtotal

Registry not part of approval

Registry part of approval

Conditional approval

9

1 (11,1%)

8 (88,9%)

Exceptional circumstances

16

0 (0%)

16 (100%)

No conditional approval or exceptional circumstances

63

32 (50,8%)

31 (49,2%)

Total

88

33 (37,5%)

55 (62,5%)