Table 1.
Similarities and differences in the pediatric legislation in the United States and European Union. Table provided by European Medicines Agency (EMA) and/or US Food and Drug Administration (FDA).
| US Best Pharmaceuticals for Children Act | US Pharmaceutical Research Equity Act | European Union | |
|---|---|---|---|
| Development | Optional | Mandatory | Mandatory* |
| Instrument | Written Request | Pediatric Study Plan | Paediatric Investigation Plan |
| Waiver | N/A | 3 grounds | 3 grounds |
| Timing | Any time adequate information available | End of Phase II | > End of Phase I |
| Reward | 6-mo exclusivity | – | Main: 6-month SPC extension (patent) |
| Orphan products | Included | Excluded | Included |
| Decision | FDA | FDA | EMA [not European Commission (EC)] Opinion: Paediatric Committee |
| Scope of pediatric development | Not limited to adult indication | = adult indication | = adult indication |
| Scientific advice | Normally in global fee | Normally in global fee | Free for paediatrics |
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Optional for off-patent.