EMA and EISMEA deepen cooperation to help life science innovators cross regulatory gaps — what it will and will not solve

Brussels, July 15th 2026

Summary

›The European Medicines Agency (EMA) and the European Innovation Council and SMEs Executive Agency (EISMEA) signed a Letter of Intent to strengthen support for health innovators, focusing on earlier regulatory engagement, training and horizon scanning.
›The cooperation builds on activity since 2021 and aims to help SMEs, spin-offs and research organisations translate discoveries into compliant health products.
›A joint survey of EIC‑funded projects found three quarters increased awareness of EMA regulatory tools after joint training, while 95% said they would reuse those tools.
›The partnership is practical but limited: it will not replace formal scientific advice or solve outstanding regulatory ambiguity on novel product classes such as engineered living materials.
›Regulators should publish clearer classification guidance, practical quality and non‑clinical expectations for emerging modalities, and expand accessible specialist support for early‑stage developers.

EMA and EISMEA step up support for health innovators — pragmatic cooperation, but not a regulatory shortcut

On 15 July 2026 the European Medicines Agency (EMA) and the European Innovation Council and SMEs Executive Agency (EISMEA) formalised a deeper working arrangement by signing a Letter of Intent. The stated objective is to help European innovators understand regulatory requirements earlier in their development cycles and better prepare technologies so that promising science can reach patients. The agreement reinforces activities the two agencies have run since 2021 and expands training, advisory touchpoints and horizon scanning to identify emerging health technologies.

What the new cooperation covers and why it matters

The partnership focuses on four practical areas where earlier regulator interaction tends to improve development outcomes: targeted advice and guidance for innovators, regulatory training and capacity building, engagement with research communities, and horizon scanning to identify new technologies that may raise policy or regulatory questions. EISMEA will continue to run EIC programmes that fund and shepherd deep tech and health projects. EMA brings regulatory expertise and tools designed to help innovators plan compliant development strategies. Both agencies say the aim is faster, safer translation of discoveries into healthcare products.

Why early regulatory engagement matters:Early interaction with regulatory experts helps teams choose the right development pathway, reduces late stage surprises and avoids wasted investment on approaches that will not meet evidence or quality expectations. It can also shorten timelines by steering applicants toward the appropriate scientific advice, classification, or compliance routes before costly trials or manufacturing scale up.

What the agreement will deliver in practice

Concretely the partnership will: expand joint training and outreach so EIC beneficiaries become more aware of EMA support tools; provide tailored advice and engagement opportunities for SMEs, start‑ups and academic spin‑outs; feed into proactive portfolio management activities driven by EIC Programme Managers; and carry out joint horizon scanning so both organisations can spot emerging technology trends and regulatory pinch points earlier.

Measured results to date:A recent survey of EIC‑funded innovators reported that about three quarters improved their awareness of EMA regulatory support after joint training activities, and 95% said they would use EMA tools again. Those figures indicate added value from outreach and training, though they do not measure downstream regulatory or clinical success.

How this fits into the broader European innovation ecosystem

EISMEA manages the EIC and related SME programmes, which provide grants, acceleration services and equity through the EIC Fund. The EIC has become a central funnel for Europe’s deep tech and health innovators, pairing grants with business acceleration services and investor matchmaking. EMA is the EU regulator for medicines and medical devices and provides product classification, scientific advice, and regulatory tools. The new Letter of Intent is an institutional recognition that funding and regulatory advice work best when they are coordinated earlier in the innovation lifecycle.

Programme or actor	Core function	Relevant figures from EIC / EISMEA sources
EIC Pathfinder	Funds high‑risk early research (TRL 1–4)	EIC Pathfinder Open 2026 budget €166 million (work programme); Pathfinder projects are funded up to €4M
EIC Transition	Maturation and validation toward market readiness (TRL ~3–6)	2026 Transition budget €100 million; grants up to €2.5M
EIC Accelerator	Support for scale‑up and clinical development; grant + equity	EIC Data Hub: total Horizon Europe grants €3.60B; EIC Fund disclosed equity €1.15B
EIC STEP Scale Up / STEP Defence	Large equity investments to catalyse €50–150M rounds	STEP 2026 budget for Scale Up €300M; STEP Defence €100M; investments €10–30M
EIC Business Acceleration Services (BAS)	Coaching, procurement matches, investor readiness, trade fairs	Supports networking and commercialisation for EIC awardees
EMA	Regulatory oversight for medicines and certain medical devices	Provides scientific advice, classification support and horizon scanning

Concrete example: how early regulator contact helped a digital twin company

Ebenbuild, an EIC‑backed company developing digital twin technology for lung disease diagnosis and treatment, was connected with EMA through EIC Programme Manager portfolio activities. Ebenbuild says early dialogue clarified regulatory expectations and helped identify appropriate development pathways. This is the type of practical outcome the Letter of Intent aims to scale, especially for smaller teams that lack in‑house regulatory expertise.

Limitations of outreach and training:Training and early engagement improve knowledge but do not replace formal scientific advice, compliance with GMP/GCP, or product classification processes. They also do not create faster formal approvals when the underlying evidence base is insufficient. Innovators still need robust non‑clinical and clinical data and suitable manufacturing controls.

A hard case in the pipeline: engineered living materials (ELMs)

The agencies plan to use joint horizon scanning to identify disruptive modalities that will test regulatory frameworks. One example already flagged by EMA’s internal horizon scan is engineered living materials (ELMs) — hybrid or purely biological materials that integrate living cells and can assemble, adapt or produce molecules in situ. ELMs for in situ therapeutic production illustrate both the promise and the regulatory complexity the partnership will confront.

What are ELMs?:Engineered living materials are materials composed partly or wholly of living cells and cell‑derived components. They range from biofilms and mycelium‑based constructs to hydrogels that embed engineered microbes or mammalian cells. Some designs are purely biological, others are hybrid systems combining abiotic scaffolds with living cells.

EMA’s horizon scanning note summarises the technical routes (secreted extracellular polymeric substances, engineered scaffolds, bioprinting, microcapsules), use cases in oncology, infection, wound care and regenerative medicine, and the core challenges: manufacturing reproducibility, stability and sterility, potency assays, containment and biosafety, and how to classify such products in existing regulatory boxes. The report emphasises that while ELMs may offer continuous local production of therapeutics and dose sparing advantages, developers face complex quality, non‑clinical and environmental assessment questions.

Regulatory classification uncertainty:ELMs often cross existing product boundaries. Depending on composition and mechanism of action they can touch advanced therapy medicinal products (ATMPs), biologicals, combination products or medical devices and can trigger genetically modified organism (GMO) legislation. EMA’s note and EU Borderline Classification Group discussions show there is not yet a harmonised EU definition or single regulatory path for many ELM designs.

Technical and regulatory pinch points for ELMs — a pragmatic checklist

The EMA horizon scan identifies multiple problems innovators will need to solve before regulatory approval is plausible. These are practical issues as well as methodological gaps where the scientific community and regulators must converge on standards.

Manufacturing and quality control:Living components make batch‑to‑batch consistency harder. Potency assays and release criteria are not yet standardised for many ELMs. Bioprinting introduces supply chain and accreditation questions: who qualifies as a manufacturer if raw material suppliers, print farms and finishing labs are separate entities?

Sterility, processing and storage:Conventional sterilisation methods are often incompatible with living components. Cold chain needs, oxygen and moisture sensitivity, and the long‑term stability of embedded genetic circuits or micro‑ecosystems must be addressed.

Biosafety and containment:For microbe‑based ELMs, containment strategies include physical encapsulation, auxotrophy and genetically encoded 'kill switches'. Each approach has strengths and weaknesses and must be demonstrated robust to mutation and environmental exposure. Environmental release rules and GMO authorisations will apply in many jurisdictions.

Non‑clinical and clinical evidence:Designing relevant toxicology, biodistribution and tumourigenicity studies is challenging for living, adaptive systems. Regulators and developers need shared expectations on suitable animal models, duration of observation, and what constitutes acceptable environmental risk assessment for clinical entry.

Where joint action can be most constructive

The Letter of Intent is a realistic, incremental response. It can reduce the knowledge gap that small teams face and direct innovators to the right formal regulatory interactions. But practical impact will depend on several downstream steps.

Priority actions that would add value:Publish pragmatic classification guidance for hybrid and living materials so innovators understand whether ATMP, biological, device or combination pathways apply. Issue targeted guidance on quality attributes and release testing for living materials, including acceptable approaches to potency and batch consistency. Expand templates and case examples for non‑clinical study designs for adaptive living systems. Scale accessible one‑to‑one regulatory coaching for EIC beneficiaries preparing clinical submissions.

Practical recommendations for stakeholders

For regulators and agencies

Publish clear, worked classification examples for ELMs and other hybrid products, including illustrative decision trees that help developers determine when ATMP or combination rules apply. Provide practical guidance on potency assay design, acceptable quality attributes, and approaches to environmental risk assessment for living materials. Continue and expand early‑stage touchpoints but be explicit about the limits of training and horizon scanning: they do not substitute for formal scientific advice and legally required assessments.

For innovators and funders

Plan regulatory engagement early and budget for iterative scientific advice and specialised non‑clinical programmes. Invest in robust analytical methods and reproducible manufacturing processes from the start. When using EIC or similar support, leverage Business Acceleration Services, investor matchmaking and procurement channels to validate commercial pathways alongside regulatory development.

For investors and ecosystem partners

Recognise that novel modalities like ELMs carry additional translational risk tied to quality, biosafety and regulatory uncertainty. Co‑invest in teams that have clear regulatory strategies, early regulatory engagement and transparent plans for containment and manufacturing scale‑up.

Final assessment

The EMA–EISMEA Letter of Intent is a constructive, practical step that aligns funding, acceleration and regulatory awareness. Early evidence suggests training and portfolio engagement increase innovators’ use of EMA tools and awareness of regulatory pathways. That said, the agencies cannot remove the fundamental scientific and evidentiary hurdles for complex new modalities. To make the most of the partnership, regulators should publish clearer, concrete guidance on classification, quality expectations and non‑clinical testing for emerging modalities such as engineered living materials, and EISMEA should continue to ensure innovators can access specialist regulatory support as part of acceleration services.

Quotations in the original announcement highlighted the complementary aims of the agencies. Emer Cooke, EMA Executive Director, framed the work as helping innovators navigate complex development pathways to tackle unmet medical needs. EISMEA Director Momchil Sabev emphasised earlier regulatory engagement reduces risk and improves the chances promising solutions reach patients. Those are sensible goals, but they presuppose developers will have the capacity and funding to follow through on more intensive regulatory programmes. The partnership reduces information asymmetry and should lower some avoidable risks, but it is not a shortcut around generating high quality evidence and building reliable manufacturing.

Glossary of key terms

EIC (European Innovation Council):EU funding and acceleration programmes for breakthrough technologies. It combines grants, business acceleration services and an equity investment arm, the EIC Fund, to help scale deep tech companies.

EISMEA:European Innovation Council and SMEs Executive Agency, the European Commission agency that manages the EIC programmes and related SME/scaleup initiatives.

EIC Fund:An EIC venture fund providing equity investments alongside private co‑investors. EIC sources include that the Fund has signed investment agreements of over €1.4bn and has a capitalisation of around €4bn.

EIC Business Acceleration Services (BAS):A set of services for EIC awardees for coaching, investor readiness, access to trade fairs, procurement matching and international expansion.

ELMs (Engineered living materials):Materials composed partly or entirely of living cells and cell products, used to create adaptive, self‑repairing or molecule‑producing constructs. ELMs can be purely biological or hybrid with abiotic scaffolds.

ATMPs (Advanced Therapy Medicinal Products):An EU regulatory category for gene therapies, somatic cell therapies and tissue engineered products. Some ELMs may fall within ATMP rules depending on composition and intended use.

Selected further reading and resources

Sources used to prepare this analysis include the EMA horizon scanning note on engineered living materials, EISMEA/EIC public pages, the EIC Data Hub and programme documents, and public announcements from both agencies. Developers should consult EMA’s scientific advice procedures and EISMEA’s EIC programme pages for practical tools and upcoming calls.