Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?
Agency IQ
JUNE 9, 2023
The problems: Although the current regulation stimulated orphan drug research, it didn’t do enough The regulation fostered development of medicines for rare diseases since implementation, but not enough. Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity.
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