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Expedited Programs: Overworked Staff & Financial Motives

Executive Summary

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.

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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.

Major Review Of EU PRIME Scheme Highlights Faster Approvals

Products developed under PRIME, the European Medicines Agency’s priority medicines scheme, are more likely to be granted accelerated assessment and maintain fast-track status than non-PRIME products, says a new report.

Hits, Misses & Key Firsts For EMA’s PRIME Scheme

The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.

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