EMA issues new guidelines for medicine shortage prevention

The European Medicines Agency (EMA) has issued new guidelines for the pharmaceutical industry regarding Shortage Prevention Plans (SPP). Marketing Authorization Holders (MAH) are now required to prepare and maintain updated prevention plans for all prescription medicines within the European Union, as well as other products identified by the European Commission.

These plans must include detailed product information, such as active ingredients, manufacturing sites, and dosage forms. A mandatory risk assessment must be conducted, evaluating two dimensions: the impact on patients resulting from supply interruptions and the structural risk of the supply chain. Based on these factors, risks will be classified into three levels: high, medium, or low.

Additionally, the EMA is addressing high volumes of requests for scientific advice, which have caused procedural delays. The agency is considering a pre-payment model for scientific consultation requests, potentially by the end of 2026, and is exploring earlier involvement from other European agencies in alignment with new pharmaceutical legislation.