Langfristige API-Lagerung und schnelle Herstellung von Fertigarzneimitteln

LOT-0001

Long-term API stockpiling and rapid finished dose form manufacture

The European Health and Digital Executive Agency (HaDEA) is planning to launch a call for tenders on "Long-term API stockpiling and rapid finished dose form manufacture", a feasibility project to assess its application in crisis preparedness. This project aims to support the development of and access to technologies that can prolong the shelf-life of Active Pharmaceutical Ingredients (APIs) stored in bulk and advanced manufacturing technologies to produce finished dose forms from those bulk APIs rapidly, enhancing crisis preparedness by exploring potential gains in sustainability, resiliency, and flexibility to respond to future health emergencies. The upcoming call for tenders will request the development of a pilot feasibility project to test this concept, assess its viability, and provide recommendations on how to operationalise the approach.