Three-Month Dry Spell For EU PRIME Scheme
Not one of the applications reviewed by the European Medicines Agency this year for a place on its scheme for drugs for unmet medical needs has made the grade. Meanwhile, the agency recently explained how applicants could improve their chances of getting accepted on the initiative.
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A shortage of staff and expertise at regulatory agencies as well as tough eligibility criteria can impact expedited programs and their capacity to help deliver quicker access to innovative products.
The first half of 2022 saw a total of seven promising treatments for unmet medical needs make it onto the European Medicines Agency’s priority medicine scheme.
This year’s first designations under the European Medicines Agency’s priority medicines scheme have gone to a maternal vaccine for an infection in newborns and a treatment for an ultra-rare bone disorder.