European Rare Disease ‘Moonshot’ Coalition Targets Unmet Needs & Innovation
The members of a new group aiming to boost rare disease R&D say that Europe needs a “solid pro-innovation ecosystem” supported by a stable intellectual property framework and a “world-class” regulatory system.
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Industry representatives told a House of Lords committee about continuing Brexit-related problems such as the extra work involved in checking compliance with the EU Falsified Medicines Directive and the drawbacks of a proposed “dual regulatory regime.”
The Medicines and Healthcare products Regulatory Agency says that the fee increases to be introduced on 1 April, along with 18 new fees, are necessary for its long-term financial sustainability and its ability to provide a “responsive, innovative and efficient regulatory service.”
The European Medicines Agency says that the current shortage of antibiotics containing amoxicillin is not a “major event” and that efforts by EU and national regulators are helping to mitigate the situation.