Expected Outcome:
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Developing and using new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim to deliver results directed towards and contributing to all the following expected outcomes:
Scope:
The Commission Communication 'Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU' [1] has recently identified research and technology transfer to the market as a major challenge for the biotechnology sector. This topic aims to speed up the development of innovative biotechnology-based therapies by supporting the initial phases of clinical research. SMEs play a key role in the EU's potential to innovate, with most biotechnology-derived drugs in development being progressed by SMEs and small biotech companies. However, transitioning from drug discovery and development stages to approved products requires substantial investment and sufficient resources in different areas (e.g., manufacturing, clinical trial management, regulatory affairs, etc.), with the time needed for clinical development often exceeding 10 years[2]. This topic targets collaborative multidisciplinary consortia of SMEs, academics, clinicians and research organisations bringing together the necessary expertise to launch the clinical development of novel biotechnology-derived therapeutics. Collaboration with the relevant European research infrastructures is encouraged. This topic does not address the full clinical development needed to bring products to market but aims to support the critical transition phase from preclinical to clinical development by supporting the early clinical phases. A non-exhaustive list of biotechnology-derived therapies in scope include monoclonal antibodies, (therapeutic) vaccines, recombinant biomolecules, Advanced Therapy Medicinal Products (ATMPs), nano-based drugs, RNA therapies etc. Whole blood, blood components and other substances of human origin are not within the scope of this topic.
Proposals submitted under this topic should include all the following elements:
The maximum project duration should not exceed four years.
Applicants should provide details of their clinical studies[3] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.
For ERC grants, excellence is the sole selection criterion—evaluations focus exclusively on the quality of the research and track record .
Peer-reviewers adhere strictly to predefined criteria (e.g., Horizon ITN evaluations), and weaknesses—rather than strengths—often decide the outcome.
Horizon Europe emphasizes Green & Digital Transitions and resilience, with specific budget steering across biodiversity, climate, digital, and societal missions .
Proposals that clearly align with these strategic orientations and EU missions are significantly more competitive.
Horizon projects demand well-balanced consortia across Europe—geographically and disciplinarily diverse, including academia, industry, SMEs, NGOs .
Effective leadership, communication, trust, and active collaboration are key success factors .
A strong publication record—especially in high-impact venues—and prior grant awards bolster chances .
ERC starting, consolidator, or advanced grants require exceptional citation records, strong proposals, and investigator track records .
For large collaborative grants, project coordination, administration, and communication are just as crucial as scientific content .
Demonstrating realistic budget planning (100% direct costs + 25% indirect costs), administrative frameworks, and governance structures strengthens proposals .
Marie Skłodowska-Curie fellowships emphasize researcher mobility, interdisciplinary training, and developing future talent .
Northern and certain Eastern European institutions currently have higher success rates (≈22% vs below 18% in Southern Europe)
ERC gender data: male and female applicants have similar success rates, though male applicants apply more frequently .
Factor | Why It Matters |
---|---|
Excellence-first | Superior science and investigator record are non-negotiable. |
Strategic fit | Alignment with EU green, digital, and mission goals is essential. |
Consortium quality | Geographic, sectoral, and expertise balance enhances impact. |
Management capacity | Good PM builds confidence in successful delivery. |
Experience track record | Publications, previous funding, and citations build credibility. |
Mobility & careers | MSCA focuses on researcher development and interdisciplinary collaboration. |
Master criteria & avoid weaknesses: Make sure your proposal addresses common reviewer pitfalls—methodology, innovation, budget clarity.
Map to EU priorities: Explicitly connect your objectives to Horizon Europe’s strategic plan (2025–2027).
Build strong consortia early: Prioritize complementary expertise, geography, gender balance, and partner roles.
Show robust project management: Include a Work Package structure, governance plans, and clear communication strategies.
Leverage your track record: Highlight high-impact papers, leadership in projects, and previous awards.
Consider MSCA opportunities: Use them for mobility grants or integrating training into your project.
✅ In Summary
To maximize success with European Commission grants—especially ERC or Horizon Europe—focus relentlessly on scientific excellence, strategic EU alignment, consortium strength, and solid project planning. Combine these with a strong publication record and researcher development elements, and aim to close off any potential reviewer concerns.
General conditions
1. Admissibility Conditions, Proposal page limit and layout
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.
2. Eligible Countries
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.
3. Other Eligible Conditions
In order to prove that the investigational product is ready for clinical testing, proposals must provide evidence of regulatory approval in the EU already in place for phase I clinical study.
The proposed EU contribution going to small and medium-sized enterprises (SMEs) must be 50% or more of the total EU contribution to the project as a whole.
In addition to the eligibility conditions as described in General Annex B, the consortium must be composed of at most 5 legal entities as beneficiaries.
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 Eligible Conditions are described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.
5a. Evaluation and award: Award criteria, scoring and thresholds
Eligible proposals submitted under this topic and exceeding all the evaluation thresholds will be awarded a STEP Seal[[https://strategic-technologies.europa.eu/about/step-seal_en]].
Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
5b. Evaluation and award: Submission and evaluation processes
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.
Evaluation and award: Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement
Evaluation and award: Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants
Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.
Specific conditions
Specific conditions are described in the specific topic of the Work Programme.
Sponsor Institute/Organizations: European Commission
Sponsor Type: Corporate/Non-Profit
Address: Rue de la Loi 200, B-1049 Brussels, Belgium.
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Sep 16, 2025
Sep 16, 2025
$9,219,776
Affiliation: European Commission
Address: Rue de la Loi 200, B-1049 Brussels, Belgium.
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