Comparison of characteristics of orphan drug regulations in Europe (EMA) and the United States (FDA)
| Incentive . | EMA . | FDA . |
|---|---|---|
| Market exclusivity period* | 10 years in all 27 member states | 7 years |
| Review process | Access to centralized review process for all 27 member states | Allows sponsor to apply for accelerated review process |
| Fees | 50% waiving of market authorization application fees | Exemption for sponsor for user fees, selected tax benefits |
| 100% waiving of fees for premarketing authorization inspection | ||
| Scientific advice (protocol assistance) | Free scientific advice during the drug development process | NA |
| Special incentives for SME† sponsors | 100% waiving of market authorization application fees | NA |
| 100% waiving of fees for postauthorization activities, including annual fees |
| Incentive . | EMA . | FDA . |
|---|---|---|
| Market exclusivity period* | 10 years in all 27 member states | 7 years |
| Review process | Access to centralized review process for all 27 member states | Allows sponsor to apply for accelerated review process |
| Fees | 50% waiving of market authorization application fees | Exemption for sponsor for user fees, selected tax benefits |
| 100% waiving of fees for premarketing authorization inspection | ||
| Scientific advice (protocol assistance) | Free scientific advice during the drug development process | NA |
| Special incentives for SME† sponsors | 100% waiving of market authorization application fees | NA |
| 100% waiving of fees for postauthorization activities, including annual fees |
SME indicates micro, small, or medium enterprise status; and NA, not applicable.
Market exclusivity for an orphan product is only for the indication(s) for which it has received orphan drug designation status. Market exclusivity is granted for the period after successful marketing authorization of a product.
In February 2009, the EMA announced changes to the orphan program where benefits were given specifically to sponsor organizations with SME status.