European Medicines Agency Updates Shortage Prevention Plan Guidance for Pharmaceutical Industry

The European Medicines Agency (EMA) has published updated guidance for the pharmaceutical industry on implementing Shortage Prevention Plans (SPPs). This revision elevates SPPs from a recommendation to a statutory requirement under new pharmaceutical regulations, effective by mid-2027. A significant change includes a revised risk assessment methodology, replacing qualitative assessments with defined criteria and numerical thresholds, which will require marketing authorization holders to maintain more detailed data.