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.

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

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