Support for companies developing medicines for rare diseases is built into EU legislation through the Orphan Regulation, but these incentives are not always suitable for products that are being developed for very rare diseases or patient-specific treatments, experts from the European Medicines Agency and European Commission have heard.
EU Regulators Developing Tools For ‘N-Of-1’ Drugs & Platform Technologies
European regulators are working with global partners to tackle challenges that sponsors face during “N-of-1” trials, where medicines are personalized to the individual, and looking at the regulation of platform technologies.
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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 Two companies have withdrawn their marketing authorization applications.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.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
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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 Two companies have withdrawn their marketing authorization applications.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.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.