THE transition period for Australia's Orphan Drug Scheme will end on 30 Jun 2018, meaning orphan designations under the previous program (prior to 01 Jul 2017) will no longer be in force after that date.
The new criteria introduced 12 months ago refocussed the program to the "consideration of greatest unmet need" with a more generous orphan disease prevalence threshold, a requirement for the condition to be life-threatening or seriously debilitating, and the introduction of a new pathway with separate eligibility criteria to seek orphan designation for new dosage form medicines.
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