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

Topic updates

12 September 2024

Call EU4H-2024-PJ-01 has closed on 05/09/2024.

15 proposals have been submitted.

The breakdown per topic is:
EU4H-2024-PJ-01-3: 8 proposals

Evaluation results are expected to be communicated in November 2024.

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

TOPIC ID: EU4H-2024-PJ-01-3

Type of grant: Call for proposals

General information

Programme: EU4 Health Programme (EU4H)

Call: HERA Action Grants - first wave (EU4H-2024-PJ-01)

Type of action: EU4H-PJG EU4H Project Grants

Type of MGA: EU4H Action Grant Budget-Based [EU4H-AG]

Status: Open for submission

Deadline model: single-stage

Opening Date: 23 May 2024

Deadline dates: 05 September 2024 17:00 (Brussels time)

Topic description

Objective:

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.

Scope:

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.

Expected Impact:

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.

Conditions

1.Admissibility conditions: described in section 5 of the call document

Proposal page limits and layout:described in Part B of the Application Form available in the Submission System

2. Eligible countries:described in section 6 of of the call document

3. Other eligibility conditions:described in section 6 of the call document

4. Financial and operational capacity and exclusion:described insection 7 of the call document

5.Evaluation and award:

• Award criteria, scoring and thresholds:described in section 9 of the call document

• Submission and evaluation processes:describedsection 8 of the call document and theOnline Manual

• Indicative timeline for evaluation and grant agreement:described in section 4 of the call document

6. Legal and financial set-up of the grants:describedin section 10 of the call document

Start submission

To access the Electronic Submission Service, please click on the submission-button next to the type of action and the type of model grant agreement that corresponds to your proposal. You will then be asked to confirm your choice, as it cannot be changed in the submission system. Upon confirmation, you will be linked to the correct entry point.

To access existing draft proposals for this topic, please login to the Funding & Tenders Portal and select the My Proposals page of the My Area section.

Get support

For help related to thiscall, please contact:HaDEA-HP-CALLS@ec.europa.eu

Funding & Tenders Portal FAQ– Submission of proposals.

IT Helpdesk– Contact the IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.

Online Manual– Step-by-step online guide through the Portal processes from proposal preparation and submission to reporting on your on-going project. Valid for all 2021-2027 programmes.