'Fund it properly or it will implode': parting comments from Aginus Kalis on EU drug regulatory network
This article was originally published in SRA
Executive Summary
“If you don’t finance it correctly, it will implode.” This was the stark warning key European drug regulator Aginus Kalis gave about the European drug regulatory network in an exclusive interview to Scrip Regulatory Affairs on his last day as executive director of the Dutch Medicines Evaluation Board.
You may also be interested in...
Submit Your Brexit-Related Changes Before We Move: EMA Plea To Industry
A continuous two-way dialogue on Brexit between the European Medicines Agency and industry is a must. The EMA is tentatively planning three Brexit-related events for stakeholders and, in the meantime, it wants companies to keep it abreast of their plans for products affected by the UK’s departure from the EU
EU Accelerated Assessment Tracker
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.
EU Accelerated Assessment Tracker
The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.