EIC and EMA invite health innovators to assess their collaboration before 27 March 2026
- ›EMA is running an EIC–EMA Collaboration survey with responses due by 27 March 2026 end of business day.
- ›The survey targets all EIC health beneficiaries to rate perceived value, specific EMA interactions and where the partnership should improve.
- ›An EMA interaction is counted as one complete engagement from first request to final advice or outcome.
- ›Covered interaction types include ITF briefings, SME Office, Scientific Advice, ATMP classification, ODD, PRIME, device advice, qualification procedures and the Quality Innovation Group.
- ›Results may inform improvements but do not in themselves commit funding, fee policies or regulatory changes.
Health innovators asked to rate the EIC–EMA collaboration
The European Medicines Agency is inviting European Innovation Council health beneficiaries to complete the EIC–EMA Collaboration survey by 27 March 2026 end of business day. The exercise seeks candid feedback on how the collaboration works in practice, what value it delivers and where it falls short for teams developing new health products.
The survey is open to EIC beneficiaries working in biotech, medtech, diagnostics, digital health, therapeutics and other health solutions. Respondents are encouraged to reflect on their direct and indirect experiences with EMA during project development and to identify concrete areas for improvement.
What the survey will assess
Respondents are asked to evaluate four areas. First, the overall perception of the EIC–EMA collaboration. Second, the value and benefits the collaboration brings to EIC beneficiaries. Third, any direct or indirect interactions teams have had with EMA during development. Fourth, specific opportunities to strengthen the collaboration to create more value for innovators.
Who should respond
All EIC beneficiaries operating in health are eligible, including companies and researchers from academia or non profit institutes. This cuts across modalities from therapeutics and advanced therapies to medical technologies, diagnostics and data driven digital health solutions. Early stage and later stage projects are both in scope.
What counts as an EMA interaction
For this survey, one EMA interaction is a single complete engagement that runs from the first formal request or contact through to the final advice, guidance, decision or outcome. Emails, written follow up questions, clarifications, meetings or administrative exchanges that belong to the same request or procedure are counted as part of one interaction. This definition applies consistently to all interaction types listed below.
EMA interaction types covered by the survey
| Interaction type | What it is | Typical purpose for innovators |
| Innovation Task Force briefing meetings | Early, cross disciplinary dialogue with EMA experts | Explore regulatory pathways and identify issues for novel products at a formative stage |
| SME Office interactions | Dedicated support for EU recognised SMEs | Obtain regulatory guidance and information on fee incentives available to SMEs |
| Support to Academia interactions | Tailored contacts supporting academic developers | Orient academic teams on regulatory expectations and when to engage formally |
| Scientific Advice and Protocol Assistance | Formal advice on development plans including study design and endpoints | De risk pivotal trials or key studies, and align plans for medicines and designated orphan products |
| Scientific Advice for Medical Devices | Advice within EMA remit on device aspects linked to medicines or specific procedures | Clarify evidence expectations for combination products or device elements associated with drugs |
| ATMP classification | Regulatory determination on whether a product is an advanced therapy medicinal product | Confirm the regulatory framework and applicable rules for cell and gene therapies and tissue engineered products |
| Orphan Drug Designation | Evaluation of eligibility for orphan status in rare diseases | Secure access to incentives and tailored development support for treatments targeting rare conditions |
| PRIME scheme | Early and enhanced support for priority medicines with potential to address unmet need | Accelerate development with iterative dialogue and potential procedural advantages once criteria are met |
| Qualification advice or Qualification of novel methodologies | Advice and opinions on the acceptability of new biomarkers, models or tools for regulatory use | Gain acceptance for innovative endpoints, biomarkers or methods in development programs |
| Quality Innovation Group | Dialogue on novel manufacturing and quality approaches | Discuss quality and manufacturing innovations such as continuous manufacturing or advanced analytics |
Survey at a glance
| Item | Detail |
| Deadline | 27 March 2026 end of business day |
| Audience | All EIC health beneficiaries including companies and researchers from academia or non profit institutes |
| Scope | Perception of the EIC–EMA collaboration, value and benefits, EMA interactions during development, and areas for improvement |
| Interaction counting rule | One engagement from initial contact to final outcome counts as one interaction even if it includes multiple exchanges |
| Covered EMA interactions | ITF, SME Office, Support to Academia, Scientific Advice or Protocol Assistance, Scientific Advice for Medical Devices, ATMP classification, Orphan Drug Designation, PRIME, Qualification advice or Qualification of novel methodologies, Quality Innovation Group |
| Organisers | European Medicines Agency in collaboration with the European Innovation Council |
| How to respond | Complete the EIC–EMA Collaboration survey via the link provided in the EIC Community announcement |
Why this matters for EU health innovators
Regulatory engagement shapes time to market, trial design, and capital efficiency. For startups and research teams backed by the EIC, the ability to access timely, proportionate and predictable EMA guidance can reduce avoidable iteration, align evidence generation with emerging standards and help investors understand regulatory risk. Conversely, unclear pathways or fragmented touchpoints often translate into costly delays or underpowered studies. A structured assessment of the collaboration can surface practical fixes such as clearer entry points, faster routing to the right expertise, or better alignment between device and medicine advice for combination products.
Potential benefits and persistent gaps to watch
The collaboration has the potential to streamline early scientific dialogue for high risk, high novelty projects funded by EIC. That said, respondents should scrutinise whether support is reaching smaller beneficiaries outside major hubs, whether advice cycles align with grant and equity funding timelines and whether guidance is sufficiently granular for digital health, diagnostics and borderline products. For medical devices, where regulation often runs through national competent authorities and notified bodies, it is worth flagging where EMA touchpoints intersect with MDR and IVDR obligations or companion diagnostics under the IVDR. Beneficiaries who have not engaged EMA directly can still provide insight on perceived barriers to entry, awareness of options like ITF and SME Office and whether communication channels through the EIC are visible and actionable.
What to include in a useful response
Document how many EMA interactions you had by type and stage of development. Note tangible outcomes such as changes to endpoints, study size, classification decisions or eligibility for incentives. Flag waiting times between request and meeting or advice, as well as clarity and usability of written outputs. If you are a device or digital health developer, explain where you needed guidance across more than one regulatory framework and whether routing was effective. Suggest concrete improvements such as earlier triage for novel modalities, joint advice sessions where device and medicine interfaces exist, or clearer templates and examples for diagnostics and software as a medical device. If you did not engage EMA, identify why and what would have enabled you to do so.
Data handling and privacy considerations
Survey responses collected by EU bodies are generally processed under Regulation 2018 1725 on data protection by EU institutions. EIC services and IT tools managed by EISMEA operate with EU Login authentication, role based access and defined retention rules and provide rights to access, rectify and erase personal data as applicable. For this survey, consult the specific privacy notice attached to the questionnaire to confirm who the data controller is, what personal data are collected, who can access them including Commission contractors if any, how long they are retained and how to exercise your rights or withdraw consent for non mandatory fields. If you use an EIC platform account to access related services, you can contact the EIC helpdesk to manage your profile and personal data and you retain the right to recourse with the European Data Protection Supervisor if needed.
What happens after the survey
The stated intent is to use input to understand how the collaboration is perceived, identify benefits and target improvements. Any resulting changes would likely concern how innovators are signposted to the right EMA interaction types, how requests are triaged and how feedback loops with EIC Business Acceleration Services operate. Changes to regulatory fees, statutory timelines or legal procedures would require formal processes beyond a survey. Respondents should therefore treat this as a chance to influence operational improvements rather than expect immediate policy shifts.
Context within the EU health innovation ecosystem
The EIC under Horizon Europe funds high risk innovation through grants and blended finance. EMA provides scientific and regulatory advice but does not fund development. Efficient collaboration can help EIC backed projects navigate complex pathways that often span medicines law, the Medical Device Regulation and the In Vitro Diagnostic Regulation. The PRIME scheme and Orphan Drug Designation can de risk investment for therapeutics, while early ITF briefings can channel emerging modalities such as advanced therapies, synthetic biology or software driven interventions into the right evidence plans. Diagnostics and digital health developers frequently face fragmented guidance between EU and national levels. Clearer signposting and joined up advice can reduce duplication and accelerate compliant innovation.
Practical next steps
Locate the survey link on the EIC Community announcement and schedule time ahead of the 27 March 2026 deadline. Collate records of EMA engagements including dates, type and written outcomes. Align inputs across your team to ensure one consistent view per project. Use free text fields to propose concrete, actionable improvements that would have saved time or clarified expectations.
About the EIC–EMA collaboration
The collaboration between the European Innovation Council and the European Medicines Agency has been established in recent years to support companies developing innovative health products. This survey is part of an ongoing effort to understand beneficiary experience and identify opportunities to improve how innovators are connected to and supported by EMA procedures. The value of the initiative ultimately depends on execution details such as response times, clarity of guidance and connectivity across regulatory silos where products straddle categories.