Long-Awaited EU Review Questions 10-Year Orphan Exclusivity
Prevalence Criterion Also Under The Spotlight
The EU Orphan Regulation and the Paediatric Regulation have helped to increase the number of products developed for rare diseases and children, but they both have some shortcomings that need to be addressed, according to an evaluation of the legislation carried out by the EU authorities. The European pharmaceutical industry has warned against opening up the legislation, saying it is “critical to maintain a stable and predictable incentives framework."
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Innovators warn against slashing incentives and argue a lack of a common definition of unmet need is a stumbling block to proposals.
Updated guidance from the UK regulator, the MHRA, outlines the rules on orphan drug applications, criteria and exclusivity periods that will apply in Great Britain after the end of the Brexit transition period.