Call for proposals to support innovative manufacturing technologies and processes in the Union for medicines production (HERA) - CP-g-24-12

This action is expected to result in:

a) more agile, simplified scale-up, sustainable and resilient manufacturing of APIs, their intermediates, finished products and/or excipients, allowing for better capacity to respond to demand surges and prevent critical shortages of critical medicines.

b) improved competitiveness of the Union’s manufacturing industry, improved Union’s strategic autonomy and more resilient Union’s industry in the field of medical countermeasures/medicines.

This action aims at supporting improved manufacturing technologies and processes that allow for a more effective, less expensive, easier to scale up, more sustainable and cleaner production of medicines in the Union. Innovations developed under this action should be designed to enable rapid scale-up of Union pharmaceutical production in the context of a health emergency or to prevent critical shortages of critical medicines. This action supports the Union’s pharmaceutical industry to be better able to respond to public health needs in the context of health emergencies and critical medicines shortages.

It does so by enabling the development of tools that contribute to the improvement and optimisation of manufacturing of medicines, with the objective of reducing production costs (e.g., related to labour and energy consumption), and facilitating compliance with the Union’s environmental occupational and social requirements, as well as the Union’s current and future needs to scale-up pharmaceutical production. This action supports the policy priority to enhance crisis preparedness and response for future health emergencies in relation to medical countermeasures with an all-threats approach, as well as preventing critical shortages of critical medicines, especially those in a situation of technological vulnerability with regards to the EU market. It implements the EU4Health Programme’s general objective of improving the availability, accessibility and affordability of crisis-relevant products (Article 3, point (c) of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (b) and (c), of Regulation (EU) 2021/522.

This action covers activities aimed at developing support for or innovations targeting the manufacturing of APIs, their intermediates and/or excipients, namely by developing:

a) novel manufacturing processes and technologies, e.g., additive manufacturing, continuous manufacturing and flow chemistry, and biomanufacturing technologies; combined or not with activities covering:

b) novel industrial manufacturing and facility designs, e.g., modular manufacturing, smart manufacturing execution systems, including automation and robotics, advanced analytics, and smart sensors, among other.

Overall, the action should contribute to increasingly sophisticated enhancements to chemical and/or biological processes or decreasing the production of polluting agents. This action is limited to manufacturing technologies and processes and does not cover innovation exclusively targeting the field of quality control.