Managed by the European Health and Digital Executive Agency (HaDEA) under the EU4Health programme, the call for tenders (HADEA/2026/OP/0021) will close on 29 September 2026. The initiative forms part of the EU’s broader efforts to enhance crisis readiness, strengthen supply chain resilience, and improve access to essential medicines during public health emergencies.
Moving beyond traditional medicine stockpiles
The project seeks to evaluate whether storing pharmaceutical substances in bulk form for extended periods could provide a more efficient alternative to maintaining large reserves of finished medicines. Traditional stockpiling strategies often face challenges related to product expiration, inventory rotation, and storage costs. Under the proposed approach, APIs would be preserved under optimized storage conditions designed to extend their shelf life. When needed, these ingredients could be rapidly transformed into finished dosage forms through agile manufacturing systems, reducing waste while ensuring timely availability of critical treatments. The concept reflects a growing international focus on pharmaceutical preparedness. Similar initiatives have already emerged in the United States, most notably the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), which aims to strengthen the country’s ability to respond to future health emergencies through strategic API reserves.
A central element of the HaDEA tender is the development of a pilot project to assess the technical, regulatory, and operational feasibility of long-term API storage and rapid pharmaceutical production. The pilot will include both accelerated and long-term stability studies conducted in line with International Council for Harmonisation (ICH) guidelines. The objective is to determine how storage conditions and packaging strategies can maximize the stability of bulk pharmaceutical ingredients over extended periods. In parallel, participating organizations will be expected to develop rapid manufacturing workflows capable of converting stored APIs into finished medicines significantly faster than conventional pharmaceutical production processes.
Innovative manufacturing technologies
To achieve this goal, the programme encourages the adoption of advanced and flexible manufacturing technologies, including:
- Continuous manufacturing systems
- Scalable production modules
- Reconfigurable manufacturing lines
These technologies are expected to enable a fast transition from stored ingredients to market-ready medicines, helping health authorities respond more effectively during future crises. The pilot will culminate in an end-to-end demonstration covering the entire process, from API storage to the production of a compliant finished medicinal product. The exercise will also generate the technical and regulatory documentation required to support potential future scale-up and deployment.
Beyond emergency preparedness, the initiative also aims to deliver broader benefits across the pharmaceutical supply chain. Long-term API storage could help reduce dependence on external supply sources, improve manufacturing flexibility, and lower the environmental impact associated with the frequent replacement and disposal of expiring medicine stockpiles. The European Commission hopes the study will provide evidence on whether this model can offer a more sustainable and resilient alternative to traditional strategic reserves.
Recommendations for future implementation
At the conclusion of the project, the selected contractor will be required to develop recommendations for scaling the approach to other pharmaceutical substances and adapting it to different crisis scenarios. The findings are expected to help policymakers assess whether long-term API reserves combined with rapid manufacturing capabilities could become a practical component of Europe’s future pharmaceutical preparedness strategy. As health systems seek new ways to increase resilience against pandemics, supply shortages, and geopolitical disruptions, the HaDEA initiative may offer a blueprint for a more flexible and sustainable model of strategic medicine supply.