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Strategic Analysis
A winning proposal must present a direct, derisked translational pipeline taking a novel antimicrobial candidate targeting priority critical pathogens (e.g., CRAB, CRE, or resistant fungi) from validated preclinical stage through GMP manufacturing to early clinical safety/efficacy testing. To capitalize on the portfolio selection rule, consortia should position clinical-stage excellence with strong regulatory engagement (EMA Scientific Advice) and US partner involvement under reciprocal funding. Crucially, addressing biological diversity and vulnerable populations directly operationalizes the European Medical Countermeasures and Critical Medicines strategies.
TRL 2 → 6
Based on programme defaults
Carbapenem resistant Acinetobacter baumanii (CRAB)
Carbapenem-resistant Enterobacterales (CRE) and third-generation cephalosporin-resistant Enterobacterales (C3GRE)
Carbapenem resistant Pseudomonas aeruginosa
Methicillin-Resistant Staphylococcus aureus (MRSA)
(Drug)-resistant Aspergillus fumigatus
(Drug)-resistant Candida spp
If necessary, finalisation of in-vivo tests in at least one animal model or, if available in humanised immune system animal models, to demonstrate the protective function of the therapeutics deemed sufficient for moving to first clinical trials.
If requested by regulators as pre-requisite for clinical studies, in-vivo tests in a non-human primate model.
Production of batches of the most promising antimicrobials candidates according to the Good Manufacturing Practices (GMP) [4] .
In human clinical safety and efficacy studies, demonstrating a clear regulatory pathway for market authorisation. Attention should be paid to critical biological and social factors such as sex, age, ethnicity, disability and vulnerability.
The scientific and clinical communities have a better understanding of and access to new and innovative products for the treatment of antimicrobial resistant bacteria and fungi, as well as for further clinical investigation.
Candidate therapies are available to treat patients for antimicrobial resistant bacteria and fungi, increasing therapeutic options for clinical deployment in the fight against Antimicrobial Resistance (AMR).
Disease burden in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative preventive, diagnostic and therapeutic approaches, digital and other people-centred solutions for healthcare.
Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and wellbeing are promoted, and the targets of the World Health Organization (WHO) Global Action Plan for the Prevention and Control of non-communicable diseases are attained, with an immediate impact on the related disease burden (Disability-Adjusted Life Years - DALYs).
Healthcare systems benefit from strengthened Research and Innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation.
Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide.
Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies).
European Medical Countermeasures Strategy
highFormulated under the Health Emergency Preparedness and Response Authority (HERA), this strategy aims to strengthen the EU's capacity to prevent, detect, and rapidly respond to cross-border health threats through medical countermeasures. It prioritizes research, advanced development, and secured access to therapeutics, vaccines, and diagnostics for critical health threats, notably antimicrobial resistance.
Evaluators expect proposals targeting AMR to clearly define translational pipelines, target product profiles (TPPs), and manufacturing scalability aligned with HERA's priorities, showing a direct pathway toward usable medical countermeasures.
WHO global action plan on antimicrobial resistance
highAdopted at the World Health Assembly in 2015, this global plan outlines five strategic objectives to ensure the successful treatment and prevention of infectious diseases with effective, safe medicines: improving awareness, strengthening surveillance, reducing infection incidence, optimizing antimicrobial use, and developing the economic case for sustainable investment in new medicines, diagnostics, and vaccines.
Evaluators expect antimicrobial development projects to address priority pathogens identified on the WHO Bacterial Priority Pathogens List (BPPL), design stewardship-aligned therapeutics, and demonstrate pathways toward global accessibility and responsible use.
EU One Health Action Plan against AMR
highAdopted in 2017, the European One Health Action Plan against Antimicrobial Resistance provides a comprehensive European framework recognizing that human health, animal health, and the environment are interconnected. It focuses on making the EU a best practice region, boosting research, development, and innovation, and shaping the global AMR agenda.
Evaluators expect proposals to demonstrate explicit alignment with EU One Health objectives, notably by detailing novel mechanisms of action that overcome existing multi-drug resistance patterns and articulating stewardship and translation strategies consistent with EU policy.
Critical Medicines Act
mediumThe Critical Medicines Act is a strategic initiative aimed at preventing shortages of essential medicines, addressing vulnerabilities in pharmaceutical supply chains, and boosting the manufacturing resilience and strategic autonomy of the EU. It provides frameworks for coordinated procurement, supply monitoring, and financial support for domestic production of critical active ingredients and therapies.
Evaluators expect proposals to address downstream supply chain robustness, avoiding vulnerable sole-source precursors, and demonstrating how the developed novel antimicrobials could be reliably manufactured and supplied within the European Health Union.
Good Manufacturing Practices (GMP)
mediumEU Good Manufacturing Practice guidelines (Directive 2003/94/EC and EudraLex Volume 4) establish minimum standards that pharmaceutical manufacturers must meet in production processes to ensure medicines are consistently high in quality, suitable for intended use, and compliant with marketing authorization requirements.
Evaluators look for clear evidence that candidate antimicrobials are being developed in adherence to regulatory quality standards, including pathways for transition from laboratory grade to GMP-compliant batches suitable for future clinical trials.
Commission's Political Guidelines for 2024-2029
lowThe Commission's Political Guidelines for 2024-2029 outline the headline ambitions and policy directions of the European Commission under Ursula von der Leyen, emphasizing sustainable prosperity, competitive decarbonisation, a European Health Union, and strengthened resilience against systemic crises.
Evaluators expect proposals to contextualize their long-term impact within the strategic priorities of the 2024-2029 mandate, demonstrating how research on climate-related health exposures underpins EU competitiveness, climate resilience, and public health protection.
WHO Global Action Plan for the Prevention and Control of non-communicable diseases
lowThis World Health Organization action plan establishes a roadmap and menu of policy options to attain nine voluntary global targets for combating cardiovascular diseases, cancer, diabetes, and chronic respiratory diseases through multisectoral collaboration and risk factor reduction.
Evaluators expect non-communicable disease proposals to trace clear linkages to WHO targets, including interventions addressing shared modifiable risk factors and integration into national primary healthcare systems.
Specific requirements
EU space data infrastructures
If the project uses satellite-based Earth observation, positioning, navigation or timing data/services, beneficiaries must use Copernicus and/or Galileo/EGNOS. Other sources may be added but not substitute EU infrastructures.
Civil applications only
Horizon Europe funds exclusively civil applications. Research with exclusive military or dual-use application is excluded.
Gender Equality Plan
Having a Gender Equality Plan (GEP) is an eligibility criterion for public bodies, research organisations, and higher education institutions from Member States and Associated Countries.
Open Science
Mandatory open access to peer-reviewed scientific publications and responsible management of research data (FAIR principles, DMP required).
Eligibility of US entities for funding
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
Exclusion of legal entities established in China
Legal entities established in China are not eligible to participate in both Research and Innovation Actions (RIAs) and Innovation Actions (IAs) falling under this destination.
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Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.
Proposal page limits and layout are described in Part B of the Application Form available in the Submission System.
Eligible countries are described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).
Other eligibility conditions are described in Annex B of the Work Programme General Annexes.
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.
To ensure a balanced project portfolio covering the pathogens targeted in this topic[[Pathogen i to vi, as given in the scope of this topic.]], grants will be awarded (within available budget) to proposals not only in order of ranking but at least also to those proposals that are the highest ranked within different pathogens targeted, provided that the proposals attain all thresholds.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5.
Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.
Specific conditions are described in the specific topic of the Work Programme.
Application and evaluation form templates
Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System
Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations
Guidance
Model Grant Agreement (MGA)
Call-specific instructions
Information on clinical studies (HE)
HE Main Work Programme 2026-2027 – 1. General Introduction
HE Main Work Programme 2026-2027 – 4. Health
HE Main Work Programme 2026-2027 – 15. General Annexes
HE Framework Programme 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation 2024/2509
Decision authorising the use of lump sum contributions under the Horizon Europe Programme
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Evaluators will rigorously assess whether the proposal commits to a realistic clinical development plan rather than purely basic science. They will prioritize:
Everything the call asks for, seen from the call's point of view. Each line shows what answers it, and which partner carries it.
This matrix lists everything the call asks for: outcomes, impacts, scope, the requirements buried in the call text, and policy alignment. Sign up free and GrantForge tracks each line against the concept you build.
| Requirement | Covered by | Carried | Status |
|---|---|---|---|
| Scope activities | |||
| SC1Carbapenem resistant Acinetobacter baumanii (CRAB) | · | · | Sign up to track |
| SC2Carbapenem-resistant Enterobacterales (CRE) and third-generation cephalosporin-resistant Enterobacterales (C3GRE) | · | · | Sign up to track |
| SC3Carbapenem resistant Pseudomonas aeruginosa | · | · | Sign up to track |
| SC4Methicillin-Resistant Staphylococcus aureus (MRSA) | · | · | Sign up to track |
| SC5(Drug)-resistant Aspergillus fumigatus | · | · | Sign up to track |
| SC6(Drug)-resistant Candida spp | · | · | Sign up to track |
| SC7If necessary, finalisation of in-vivo tests in at least one animal model or, if available in humanised immune system animal models, to demonstrate the protective function of the therapeutics deemed sufficient for moving to first clinical trials. | · | · | Sign up to track |
| SC8If requested by regulators as pre-requisite for clinical studies, in-vivo tests in a non-human primate model. | · | · | Sign up to track |
| SC9Production of batches of the most promising antimicrobials candidates according to the Good Manufacturing Practices (GMP) [4] . | · | · | Sign up to track |
| SC10In human clinical safety and efficacy studies, demonstrating a clear regulatory pathway for market authorisation. Attention should be paid to critical biological and social factors such as sex, age, ethnicity, disability and vulnerability. | · | · | Sign up to track |
| Expected outcomes | |||
| EO1The scientific and clinical communities have a better understanding of and access to new and innovative products for the treatment of antimicrobial resistant bacteria and fungi, as well as for further clinical investigation. | · | · | Sign up to track |
| EO2Candidate therapies are available to treat patients for antimicrobial resistant bacteria and fungi, increasing therapeutic options for clinical deployment in the fight against Antimicrobial Resistance (AMR). | · | · | Sign up to track |
| Other requirements | |||
| REQ1Timely engagement with regulatory bodiesAll projects funded under this topic are expected to engage with regulatory bodies in a timely manner to ensure the adequacy of the actions from a regulatory point of view. | · | · | Sign up to track |
| REQ2Participation of third countries with endemic AMR or ongoing outbreaksParticipation of third countries where AMR bacteria and fungi in the proposal are endemic or where outbreaks have occurred or are ongoing is encouraged. | · | · | Sign up to track |
| REQ3Participation of start-ups and SMEsThe participation of start-ups, micro, small, and medium-sized enterprises (SMEs) is encouraged to strengthen scientific foundations, enhance innovation, and explore commercial exploitation. | · | · | Sign up to track |
| REQ4Synergies with European Partnership on One Health AMRProposals should advance research by leveraging existing and emerging state-of-the-art research initiatives such as the co-funded European Partnership on One Health Anti-Microbial Resistance (EUP OHAMR). | · | · | Sign up to track |
| REQ5Completion of dedicated clinical studies annex templateApplicants should provide details of their clinical studies in the dedicated annex using the template provided in the submission system, which is strongly encouraged. | · | · | Sign up to track |
| REQ6Mandatory use of Copernicus and Galileo/EGNOS satellite dataIf projects use satellite-based earth observation, positioning, navigation, and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS. | · | · | Sign up to track |
| REQ7Synergies and cooperation between EU-funded projectsThe Commission encourages cooperation between EU-funded projects to enable cross-fertilisation through joint workshops, exchanging knowledge, adopting best practices, or joint communication activities across Horizon Europe pillars and clusters. | · | · | Sign up to track |
| REQ8Synergies with the EU4Health ProgrammeApplicants are encouraged to explore funding opportunities available through the EU4Health Programme (2021-2027) to capitalise on potential collaborations and maximise impact. | · | · | Sign up to track |
| Expected impacts | |||
| EI1Disease burden in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative preventive, diagnostic and therapeutic approaches, digital and other people-centred solutions for healthcare. | · | · | Sign up to track |
| EI2Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and wellbeing are promoted, and the targets of the World Health Organization (WHO) Global Action Plan for the Prevention and Control of non-communicable diseases are attained, with an immediate impact on the related disease burden (Disability-Adjusted Life Years - DALYs). | · | · | Sign up to track |
| EI3Healthcare systems benefit from strengthened Research and Innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation. | · | · | Sign up to track |
| EI4Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide. | · | · | Sign up to track |
| EI5Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies). | · | · | Sign up to track |
| Underlying policies | |||
| POL1european medical countermeasures strategyFormulated under the Health Emergency Preparedness and Response Authority (HERA), this strategy aims to strengthen the EU's capacity to prevent, detect, and rapidly respond to cross-border health threats through medical countermeasures. It prioritizes research, advanced development, and secured access to therapeutics, vaccines, and diagnostics for critical health threats, notably antimicrobial resistance. | · | · | Sign up to track |
| POL2who global action plan on antimicrobial resistanceAdopted at the World Health Assembly in 2015, this global plan outlines five strategic objectives to ensure the successful treatment and prevention of infectious diseases with effective, safe medicines: improving awareness, strengthening surveillance, reducing infection incidence, optimizing antimicrobial use, and developing the economic case for sustainable investment in new medicines, diagnostics, and vaccines. | · | · | Sign up to track |
| POL3eu one health action plan against amrAdopted in 2017, the European One Health Action Plan against Antimicrobial Resistance provides a comprehensive European framework recognizing that human health, animal health, and the environment are interconnected. It focuses on making the EU a best practice region, boosting research, development, and innovation, and shaping the global AMR agenda. | · | · | Sign up to track |
The binding rules of this call. Items marked auto are verified by GrantForge from the call and the template. The others are yours to confirm.
LMIC entities auto-eligible
Low/middle-income country entities are automatically eligible for funding.
EU space data infrastructures
If the project uses satellite-based Earth observation, positioning, navigation or timing data/services, beneficiaries must use Copernicus and/or Galileo/EGNOS. Other sources may be added but not substitute EU infrastructures.
Civil applications only
Horizon Europe funds exclusively civil applications. Research with exclusive military or dual-use application is excluded.
Gender Equality Plan
Having a Gender Equality Plan (GEP) is an eligibility criterion for public bodies, research organisations, and higher education institutions from Member States and Associated Countries.
Open Science
Mandatory open access to peer-reviewed scientific publications and responsible management of research data (FAIR principles, DMP required).
Eligibility of US entities for funding
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
Exclusion of legal entities established in China
Legal entities established in China are not eligible to participate in both Research and Innovation Actions (RIAs) and Innovation Actions (IAs) falling under this destination.
5 key insights you must internalise before writing. Each is grounded in the call text and tells you what evaluators will actually look for. Share these with your consortium before drafting.
Proposals must exclusively target only one of the six listed pathogens (e.g., CRAB, CRE, MRSA). Evaluators will apply a portfolio selection mechanism to ensure balanced coverage across these targets, meaning selecting a less crowded pathogen could significantly increase funding chances compared to highly competitive targets.
Source: Scope
Due to reciprocal NIH-EU provisions, legal entities established in the US are eligible to receive Union funding. Consortia should strategically integrate top-tier US clinical or research partners to strengthen the global translational pipeline and regulatory viability.
Source: Eligibility rules
The development of phage-therapies is strictly excluded from this call. Applicants must instead focus on antibacterial and antifungal agents, such as antibody-based therapies, that meet at least one of the WHO innovation criteria for new chemical classes, targets, or modes of action.
Source: Scope
Evaluators have zero tolerance for generic clinical trial designs. Proposals must demonstrate a derisked translational pipeline by including certified GMP manufacturing partners for batch production and detailing an explicit EMA regulatory roadmap for first-in-human trials.
Source: Evaluation_pre_award
The evaluation thresholds are raised to 4.0 out of 5 for all three criteria (Excellence, Impact, Implementation), with a cumulative threshold of 12. A proposal with a visionary scientific concept but a weak clinical development plan or ambiguous preclinical efficacy will fail immediately.
Source: Eligibility rules
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