What happened
EMA issued guidance describing how marketing authorisation holders should establish, maintain and update Shortage Prevention Plans for prescription-only human medicines in EU/EEA countries. Plans may group products sharing a supply chain, provided product-level minimum data can be supplied within two days of a request. The guidance sets out product information, patient-impact assessment, supply-chain mapping, shortage history, risk classification and proportionate management measures. It also identifies additional crisis-related information for listed critical medicines, including production and supply capacity, alternative sites and minimum stock levels. Plans should be updated after relevant changes and may form part of annual product quality review.
Why it matters
From a GMP and manufacturing perspective, the guidance may require coordinated, documented visibility across active-substance and finished-product sites, production volumes, suppliers, vulnerabilities, quality defects, batch rejections and recalls. Its risk-based approach links supply-chain resilience with patient impact and calls for controls covering disruption detection, authority notification, demand forecasting, effectiveness checks and plan updates. Applying ICH Q9 and Q12 may help integrate shortage planning with quality-risk and product-lifecycle processes.
Key topics: Shortage Prevention Plans for prescription medicines, Supply-chain vulnerability and patient-impact classification, Risk-based shortage management measures
Source: European Medicines Agency (EMA)