Shortage Prevention and Mitigation Plans a Reality for Compliance

On June 18, 2024, the EMA issued templates for Shortage Prevention Plans (SPPs) and Mitigation Plans (SMPs). Marketing authorization holders (MAHs) in the European Union/European Economic Area are encouraged to create SPPs to minimize the risk of medicinal shortages. SPPs are already obligatory under Regulation 2022/123 for drugs listed in the list of critical medicines for that particular crisis, and the US has similar guidance.

Shortage Prevention Plans help to identify and manage potential risks in the supply chain and include information on the MAH, the supply and manufacturing chain, key data on stock, sales, consumption, and manufacturing, and an analysis of the history of supply issues. A SPP should be in place for each medicinal product marketed by the MAH. The minimum requirements for the SPP state that MAHs should analyze and evaluate weaknesses in the supply chain. The robustness of shortage prevention measures is to be evaluated. MAHs are obliged to assess the risks of supply interruptions for patients. A medicine shortage risk register should be developed to identify clinically significant products based on therapeutic use and availability of substitutes. Using available information, such as root cause analysis of shortages, the MAH must determine whether corrective and preventive actions or revalidation are needed nationally and internationally. Furthermore, MAHs should maintain minimum stock levels at national levels. Measures to prevent drug shortages should be reviewed regularly.

Shortage Mitigation Plans are designed to eliminate potential or actual drug shortages and minimize the impact on patients. The minimum requirements for the SMPs include procedures for dealing with shortages, from identification to resolution. These procedures should include measures to reduce the shortage’s impact, notification to regulatory authorities, and follow-up actions. MAHs should define roles, responsibilities, and escalation processes and maintain records of root causes and mitigation measures after resolving shortages.

Both should be readily available for submission upon request and can be subject to inspection during GMP and/or GDP inspections or inspections of MAHs. Thus, they should be living documents in the quality system together with the SMF, contamination control strategies, APQRs, and other similar apex documents.