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Pilot Shows EU Needs A ‘Robust’ Shortage Signaling System for ‘Critical’ Drugs

 
• By Ian Schofield

EU pharma companies see manufacturing and logistics issues as the main cause for supply problems, but are concerned about the costs of investing in and gaining regulatory approval for new or updated production facilities, according to a new report.

pharmaceutical production line
Manufacturing issues are the root cause of many drug shortages • Source: Shutterstock

The EU needs a “robust signaling system” that can accurately detect and mitigate vulnerabilities in the supply chains for “critical” medicines using a risk-based approach with harmonized definitions and quality standards, says a new report from the European Commission’s Health Emergency Preparedness and Response Authority (HERA).

Marketing authorization holders (MAHs) see manufacturing and logistical issues as the main reasons for supply chain discontinuities, notably the complexity of production processes and the cost of investing and gaining...

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