EMA has introduced Shortage Prevention and Mitigation Plans, supported by pilot implementation and enhanced monitoring through the European Shortages Monitoring Platform. In parallel, the EU pharmaceutical reform is reinforcing expectations around supply continuity and proactive risk management.
Although final legal timelines are still evolving, the direction is clear: shortage prevention is becoming an embedded regulatory expectation.
Companies should now start focusing on building robust systems for risk identification, mitigation planning, and integration into quality and regulatory frameworks.
As a Regulatory, Scientific & Safety Consulting in Life Sciences, we support organisations in preparing for these evolving requirements.
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