FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EU Considers Harmonized Drug Shortage Definition

Feb. 20, 2019
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The European Medicines Agency said the lack of a standard definition for drug shortages in the EU is preventing regulators from developing an EU-wide strategy for handling shortages. 

One-third of EU member states collect information on shortages, but the type of data gathered varies widely from one state to another, the agency said in a report based on a November 2018 workshop.

Participants in the workshop welcomed a common definition and notification system but warned about possible “information overload.”

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