The Belgian presidency of the Council of the EU says it agrees in principle with the European Commission’s proposed “modulated approach” to regulatory data protection (RDP) and market exclusivity (ME), including a cut in the baseline RDP period, as part of the pharmaceutical reform package.
EU Pharma Reform Talks Heat Up As Health Ministers Prepare To Challenge Proposals
In a sign of difficult negotiations to come on the European Commission’s pharma reform package, the presidency of the Council of the EU has drawn up its own set of proposals on regulatory data protection and market exclusivity that differ in several respects from those of the commission and the European Parliament.
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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 Two companies have withdrawn their marketing authorization applications.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 Two companies have withdrawn their marketing authorization applications.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.