Il-Belġju – Servizzi ta' riċerka u żvilupp sperimentali – Long-term API stockpiling and rapid finished dose form manufacture

L-Awtorità Eżekutiva tal-Saħħa u Digitali tal-Ewropa (HaDEA) qed tippjana tlaġġa' għall-ħidma ta' "Long-term API stockpiling and rapid finished dose form manufacture", proġett ta' fattibbilità biex tassessa l-applikazzjoni tiegħu fl-istħarrija tal-krizi. Dan il-proġett jista' jissostni l-ivvlupp u l-akkess għall-teknoloġiji li jistgħu jiprolungaw il-ħajja tal-ħażna tal-APIs (Active Pharmaceutical Ingredients) stokkati f'bulk u teknoloġiji ta' manufattura avanzata biex jipproduċu forma finali tal-dożi minn dawn il-ħażna tal-APIs f'bulk, b'mod li jippotenzja l-istħarrija tal-krizi b'ħidma l-potenzjali għall-sostenibbilità, resiljenza u fleksibilità biex jirrispondu għal-emerġenzi tal-saħħa tal-futur. L-ħidma tal-ħidma li għaddew tippjana tiddemanda l-ivvlupp ta' proġett pilota ta' fattibbilità biex tiġi l-konċett, tassessa l-viabilità tiegħu u tipprovdi rkomandazzjonijiet kif jista' joperazzjona l-approċċ.

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.