Table 3.

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

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.