From 1 January, pharmaceutical companies seeking a marketing authorization from the UK regulator, the MHRA, can use the new International Recognition Procedure (IRP), under which the MHRA will be able to take account of approval decisions taken by seven other world regulators.
UK’s New International Recognition Procedure A ‘Win-Win’ For Stakeholders
Companies wanting to use the new accelerated procedure will be paying more than £68,000 for the privilege, and will have to inform the UK medicines agency of any divergent decisions by reference regulators.
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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
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Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.