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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%)