Deadline: 5-Sep-24
The European Commission (EC) has announced a call for proposals to support innovative manufacturing technologies and processes in the Union for medicines production.
Objectives
- 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 need s 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.
Strand (scope)
- Crisis preparedness
Challenges
- Having in mind the specific focus of the grant for developing new manufacturing technologies for the production of APIs, intermediates, finished products and/or excipients, and the expected impact, projects awarded under this grant shall address one or more of the following challenges:
- Optimizing existing manufacturing processes to improve efficiency, reduce costs, and/or improve product quality.
- Developing technologies to enable rapid scale-up of production of medicines.
- Developing new technologies for manufacturing medicines in real-time.
- Developing new technologies for manufacturing medicines in remote or resource-constrained settings.
- Designing manufacturing processes that are resilient to climate change and other environmental threats.
- Developing new manufacturing technologies for the production of high-potency APIs, which are difficult to produce using traditional/resource limited methods.
- Optimizing/developing new manufacturing processes for personalized medicines, which require individualized dosing and formulation.
- Developing new manufacturing technologies that can be used to produce medicines in extreme environments.
- Developing new technologies for recycling or upcycling waste generated during medicines’ production.
- The grant supports the design and development of manufacturing technologies, processes and facilities that adhere to Good Manufacturing Practices principles. At the same time, and with the understanding of the challenges regarding the adoption of new technologies in the pharmaceutical sectors, this grant also supports relevant work developed in the context of regulatory affairs in order to ensure the future successful implementation of manufacturing processes and technologies in the EU. For example, to allow early communication with competent authorities to understand their regulatory expectations and identify potential challenges.
Funding Information
- The estimated available call budget is EUR 149 000 000.
- Topic budget: EUR 17.000.000
- Indicative project budget: EUR 5.600.000
- Expected number of grant agreements to be signed: 3
- Duration: 24 to 48 months
Expected Impact
- This action is expected to result in:
- 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.
- 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.
Mandatory Deliverables
- Communication plan: to disseminate information about the project’s achievements and outcomes to stakeholders interested in such technological developments.
- Regulatory interaction plan (if applicable): plan to allow to effectively navigate the regulatory landscape and bring innovative manufacturing technologies to market in a timely and compliant manner.
- Pilot trial results: report on the completion of pilot lab/plant trials to validate the performance and feasibility of the innovative technologies.
- Commercialisation roadmap: detailed roadmap outlining the strategy for commercialising the developed technologies and processes.
- Technical documentation: detailed documentation product of the developed innovative manufacturing technologies and processes, including technical specifications, design drawings, and user manuals.
- Training materials: development of training materials for internal staff and potential licensees on the use and implementation of the innovative technologies.
- Patent application(s): patent application(s) filed for the developed technologies and processes and other relevant registrations related to the technology.
- Final project report: comprehensive report summarizing the project’s objectives, methodology, findings, conclusions, and recommendations.
Milestones
- Communication plan implementation.
- Technology design/development completed.
- Prototype fabrication completed.
- Pilot trial completed. Patent application filed.
Activities that can be funded
- This action covers activities aimed at developing support for or innovations targeting 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, 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.
Eligibility Criteria
- In order to be eligible, the applicants (beneficiaries and affiliated entities) must:
- be legal entities (public or private bodies)
- be established in one of the eligible countries, i.e.:
- EU Member States (including overseas countries and territories (OCTs))
- eligible non-EU countries:
- listed EEA countries and countries associated to the EU4Health Programme
For more information, visit EC.