Biotech and biomanufacturing
From start-up to scaling up, this page is your EU biotech and biomanufacturing hub that provides tools and resources to help you succeed in the biotech and biomanufacturing sector:
- Check what you need to do to bring a biotech or biomanufacturing solution to market: Learn about the essential regulations and requirements to bring your biotech ideas to life.
- Find research infrastructures for your biotech or biomanufacturing R&D: Access cutting-edge facilities and data-sharing platforms to advance your research.
- Scale up your biotech or biomanufacturing business: Connect with networks, funding, market insights, pilot and testing facilities to grow your company.
Bringing a biotech solution to the market
If your company intends to develop a biotech or biomanufacturing solution in the EU, you need to be aware of the rules that apply. Support is available that can help you develop your innovation and ensure it receives marketing authorisation in the EU.
Human health: medicinal products, therapies and medical devices
If your company wants to bring medicines or products intended for human use to the EU market, they must receive a marketing authorisation which ensures that the medicine is safe, effective, and of high quality.
Medicines for human use
Medicines for human use can be authorised in two ways in the EU:
- Centralised authorisation: This is granted by the European Commission, based on a scientific evaluation from the European Medicines Agency (EMA). This route is required for biotech-based medicines.
- National authorisation: This is managed by national authorities and can involve either a mutual recognition or a decentralised procedure (in both cases countries agree on an approval), or a national single-country procedure.
The requirements and procedures for marketing authorisation, as well as the rules for monitoring authorised products are laid down in the EU directive on rules for the authorisation and labelling of all medicines and the EU regulation on medicines authorisation at EU level. These requirements apply to all medicines to be placed on the EU market (including advanced therapy medicinal products, orphan medicines, and paediatric medicines).
Clinical trials
EU rules in clinical trials set out a unified process for submitting, validating, and approving clinical trial applications. While individual EU countries are responsible for assessing and overseeing trials, the same steps apply everywhere, making the process consistent.
To better understand national requirements, you can consult the Q&A document on the Clinical Trials Regulation, which you can find in Eudralex Volume 10.
See also
Contact points at the European Medicines Agency
Contact points of national authorities responsible for medicinal products for human use
Role of the European Medicines Agency (EMA)
The European Medicines Agency (EMA) is responsible for the scientific evaluation and supervision of medicines which are authorised by the Commission through the centralised procedure. The EMA provides guidance and evaluation at all stages of a medicine's development. This includes:
- Research and development: guidance and support to medicines developers
- Marketing authorisation: support in the run up to the submission and scientific evaluation of centralised marketing authorisation applications
- Post-authorisation: safety monitoring of medicines on the market, through pharmacovigilance, applications for variations to the market authorisation and reporting product defects or recalls.
There are also various EU incentives and rewards to encourage research and development of specific types of medicines:
- Medicinal products for rare diseases (‘orphan medicines’): EMA support for developers working on biological products intended for rare diseases.
- Medicinal products for children: EMA support for developers working on biological products intended for children.
Additionally, if your company qualifies as a micro, small or medium enterprise (SME), you will have access to dedicated support and incentives, including reduced fees for scientific advice, regulatory and procedural assistance, and early dialogue through the EMA SME Office.
See also
EU directive on rules for the authorisation and labelling of all medicines
EU regulation on medicines authorisation at EU level
Biological medicinal products
If your company is developing biological medicinal products such as vaccines or monoclonal antibodies, knowing EU rules is essential for bringing your product to the market. Here are the key things you need to know.
How to obtain a marketing authorisation for your product
- Centralised authorisation: if your product is biotech-derived or an advanced therapy medicinal product (ATMP) such as a gene therapy, tissue-engineered or somatic cell therapy medicinal product, you must submit an application to the European Medicines Agency (EMA). Based on the EMA's positive assessment, the European Commission will grant a marketing authorisation.
- National authorisation: for certain types of biologicals (naturally derived biologicals), you may need to work directly with national authorities in individual EU countries.
GMO assessment for biological products
If your product under clinical trials contains or consists of GMOs, it must undergo a GMO assessment under EU rules on deliberate release and contained used of GMOs.
EMA support and resources
EMA provides scientific guidelines on biological active substance and biological medicinal products to help medicine developers prepare marketing authorisation applications for human medicine.
EMA also offers support and services to help companies develop quality, safety, and efficacy data that meet regulatory standards. You can request such advice to clarify the design of pre-clinical studies and clinical trials, and the data requirements to support benefit-risk assessments.
- Scientific advice: you can benefit from advice on the most appropriate ways to generate evidence on your medicine’s benefits and risks or the qualification of innovative development methods for biological products by requesting EMA scientific advice.
- Special programmes for innovative biological products: if your product addresses an unmet medical need, you might qualify for the Priority Medicines (PRIME) scheme, which is an enhanced support programme for faster development and assessment.
- Early consultations for innovative biological products: you can engage with experts early by requesting assistance from the EMA’s Innovation Task Force (ITF), which can provide guidance on navigating regulatory requirements for innovative products or the Quality Innovation Group on innovative approaches of manufacturing and quality control of biological medicines.
See also
EMA services and support overviewAdvanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs) such as gene therapies, tissue-engineered products, and somatic cell therapy medicinal products must in addition to the general rules applicable to medicinal products meet specific EU standards before reaching the market.
EU rules on ATMPs
- Approval and quality standards: ATMPs require EU marketing authorisation, which demonstrates quality, safety, and efficacy. Applications go through the European Medicines Agency (EMA), which assesses products intended for EU-wide authorisation.
- Good manufacturing and good clinical practice standards: Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines apply to ATMPs.
GMO assessment for ATMPs
If your ATMP contains or consists of genetically modified organisms (GMOs), it will need a GMO safety assessment. Check the EMA guidance for more information.
Accessing EMA guidance
The EMA offers comprehensive support, and resources to guide companies through the development, application, and regulatory stages specific to ATMPs. You can also apply for consultations that will allow you to clarify technical and regulatory questions early in the development of your product.
ATMP Regulation incentives and EMA support
- Fee reductions: the EMA offers reduced fees for scientific advice to help SMEs navigate the complex requirements for ATMP developments.
- Scientific classification recommendations: the EMA provides recommendations on ATMP classification, helping companies establish whether or not their product qualifies as an ATMP and, if so, under which specific category.
- Quality and non-clinical data certification for SMEs: the EMA can evaluate and certify quality and non-clinical data, which can facilitate future applications for clinical trials or marketing authorisations.
See also
EU regulation on advanced therapy medicinal products
EMA advanced therapy medicinal products overview
Legal framework advanced therapies
Substances of human origin (SoHO)
In the EU, substances of human origin (SoHO), such as blood, tissues, cells, and organs, are essential for medical therapies like transfusions and transplants. They are also used as starting materials for certain medicinal products, including plasma-derived products and advanced therapy medicinal products (ATMPs).
To ensure safety and quality, all stages of handling SoHO must comply with specific EU rules and guidelines:
- Blood and blood components: EU rules set standards for the collection, processing, testing, and use of blood products, ensuring they are safe for patient use.
- Tissues and cells: EU rules govern the donation, collection, and use of tissues and cells, including those used in medicine, ensuring their quality and traceability.
- Organs: EU rules also apply to organ donation and transplantation, ensuring safety throughout the process.
The EU maintains a Tissue Establishment Compendium, which lists the establishments that are authorised to provide starting materials for medicinal products. You can use this registry to find approved suppliers and ensure that the materials you use are safe.
For additional regulatory queries or guidance on implementing SoHO rules, you can contact the EU’s SoHO coordination board at sante-soho@ec.europa.eu.
See also
EU directive on quality and safety of substances of human origin
Medical devices
EU rules regarding medical devices aim to ensure safety, innovation, and efficient market access. Understanding EU rules can help you navigate the regulatory landscape and maximise opportunities on the EU market. There are strict rules regarding medical devices in the EU that ensure they are safe and effective for use.
Regulatory framework
The medical device sector in the EU is overseen by specific bodies tasked with assessing such products (known as “notified bodies”) and national authorities. These bodies work together to ensure that medical devices meet all the necessary safety and quality standards before they are sold. The European Commission helps coordinate the work of national authorities and other actors.
Certification and CE marking
To sell a medical device in the EU, it must undergo a conformity assessment which is done with the involvement a notified body for all except the lowest risk devices. This process ensures that the manufacturer has a quality management process, and the device is safe and effective for its intended purpose. The notified body will issue one or more certificates. After this the device can be labelled with the CE mark, showing that it meets all EU requirements.
Safety and performance requirements
The rules aim to provide a high level of protection for patients by ensuring that medical devices perform as expected. These requirements cover aspects like manufacturing processes, design and clinical performance including its follow-up after the device is placed on the market. Devices are also subject to ongoing surveillance and vigilance once they are on the market to detect any potential risks or issues.
In vitro diagnostic medical devices
If your product is an in vitro diagnostic medical device, such as a test kit or diagnostic instrument, which tests human specimens for medical purposes, it must comply with specific EU rules. These devices are subject to similarly rigorous safety and performance standards as medical devices, but with some specific differences related to their intended purpose.
Resources and support
The Medical Device Coordination Group provides guidance on various topics from device risk classification to safety reporting. These resources help ensure your device meets the necessary standards for the market.
If you have specific questions about carrying out a clinical study on a medical device or placing a device in the market in a particular EU country, contact the national competent authorities in that country. They can provide detailed guidance on any country-specific requirements.
See also
Health Technology Assessment (HTA)
Once a new medicine has received EU marketing authorisation, you can sell it in all EU countries. The decision to launch a medicine in a given EU country is an individual decision by the company. An application for pricing and reimbursement needs to be filed separately in each EU country.
What is an HTA?
A health technology assessment (HTA) summarises information about medical, economic, social and ethical issues related to the use of a health technology. Examples of health technologies include medicinal products, medical equipment for diagnostic and treatment and prevention methods. When HTA bodies evaluate a new health technology, they assess whether it works better, equally well, or worse than existing alternatives. For this, they assess the therapeutic effect of the drug, as well as potential side-effects and influence on quality of life.
EU-wide joint assessments
There is an EU HTA legal framework that offers advantages for biotech SMEs:
- Joint clinical assessment: a single harmonised assessment reduces duplication and saves time by replacing multiple national clinical assessments.
- Early joint scientific consultations: joint scientific consultations provide coordinated advice on study design for a given health technology, helping SMEs align with expectations across the EU to facilitate the generation of evidence that meets the likely evidence requirements of a subsequent joint clinical assessment on that health technology.
- Focus on clinical evidence: joint clinical assessments focus only on clinical effectiveness, creating a solid foundation for national pricing and reimbursement decisions.
- Faster market access: standardised procedures and methods developed within the EU HTA legal framework can make it easier to navigate HTA processes and can contribute to improved access to innovative technologies, such as medicines and certain medical devices, for EU patients.
The joint efforts to streamline clinical assessments makes it easier for you to focus on innovation and bringing your product to the market.
See also
Veterinary medicinal products
Medicines intended for animal use must be safe, effective, and of high quality, while also promoting environmental protection and public health. This includes safeguarding against risks like antimicrobial resistance.
Veterinary medicinal products
Medicines for veterinary use can be authorised in two ways in the EU:
- Centralised authorisation: This is granted by the European Commission, based on the scientific evaluation of the European Medicines Agency (EMA). This route is required for certain biotech-based veterinary medicines.
- National authorisation: This is managed by national authorities and can involve either a decentralised procedure, a mutual recognition procedure or a subsequent recognition procedure (in all three procedures several countries agree on an approval), or a national (single-country) procedure.
The requirements and procedures for marketing authorisation, as well as the rules for monitoring authorised products are laid down in the EU veterinary medicines regulation.
The EMA provides guidance and scientific evaluation at all stages of the centralised authorisation process and processes common to all veterinary medicines, including:
- Research and development stage: how to design and run clinical trials for veterinary medicines, compliance standards, how to establish maximum residue limits for veterinary medicines, and developing medicines for veterinary limited markets.
- Marketing authorisation stage: how to obtain a centralised authorisation for a veterinary medicine.
- Post-authorisation stage: safety monitoring of veterinary medicines on the market, through pharmacovigilance, applications for variations to the marketing authorisation, submitting product data to the EMA, and reporting product defects or recalls.
Additionally, if your company qualifies as a micro, small or medium enterprise (SME), you will have access to dedicated support and incentives, including reduced fees for scientific advice, regulatory and procedural assistance, and early dialogue through the EMA SME Office.
Clinical trials for veterinary medicines
Clinical trials for veterinary medicines are regulated at the national level in each EU country. However, there is guidance available for multicentre/multinational trials, which can help streamline the process.
The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDv) for veterinary medicinal products offers resources and guidance for conducting these trials.
GMO assessments
If your veterinary medicine involves genetic modification (e.g. the use of recombinant DNA technology), it will be subject to the EU GMO Framework (see links below), already at the stage of veterinary medicine under investigation. This framework ensures the safety of genetically modified organisms including their use in veterinary medicinal products.
Residues in foodstuffs of animal origin
If your veterinary medicine is used in food-producing animals, such as those used for production of meat, milk, or eggs, you must ensure that any residues left in foodstuffs of animal origin are within the established safe limits for human consumption (maximum residue limits).
See also
EMA veterinary medicine regulatory overview
EU regulation on veterinary medicines
EU regulation on maximum residue levels for veterinary medicines
EU GMO Framework relevant for veterinary medicines
Food, feed, and consumer products safety
Whether you are developing innovative ingredients for food or feed, novel foods, GMOs, or sustainable pesticides, understanding EU requirements can help you bring safe, compliant products to market while meeting consumer or user expectations.
Food improvement agents: additives, enzymes, and flavourings
In the EU, food improvement agents include food additives, food enzymes, and food flavourings.
- Food additives, among others, preserve, colour and stabilise food during its production, packaging or storage
- Food enzymes have specific biochemical actions which serve technological purposes at any stage of the food chain
- Food flavourings give or change the odour or taste to food.
Authorisation process
In order for the product to be legally placed on the market, it must undergo a common authorisation procedure. for the assessment and authorisation of food additives, food flavourings and source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs. The European Food Safety Authority (EFSA) conducts risk assessments as part of this process.
Find more on the general framework for food improvement agents.
See also
Feed additives
If your company produces feed additives, knowing EU rules is essential for bringing your products to the market. Here’s a summary of the standard procedure:
- Submit your application to the European Commission: you must demonstrate that your additive is safe (for humans, animals, and the environment) and efficacious for its intended purpose.
- Scientific evaluation by EFSA: the European Food Safety Authority (EFSA) evaluates the safety and efficacy of feed additives and issues an opinion.
- EU Commission decision: based on EFSA’s evaluation, the Commission grants or denies the authorisation.
For detailed information, see the EU Feed Additives Authorisation Guide.
Special procedures for feed additives containing, consisting of, or produced from GMOs
If your feed additive contains, consists or is produced from GMOs:
- You need two authorisations: one under the GMO rules and one under the feed additives rules.
- The GMO authorisation must be granted first.
Please note: for additives produced with GMOs (but not containing, consisting of, or produced from GMOs) the standard procedure applies.
See also
EU regulation on feed additives
Novel foods
'Novel food’ means any food that was not used for human consumption to a significant degree within the Union before 15 May 1997 and that falls under at least one of the categories listed in the EU regulation on novel foods.
Authorisation process
Only novel foods authorised and included in the “Union list of novel foods” may be placed on the market. The novel food authorisation procedure ensures that only safe novel foods reach the EU market. In this procedure, risk assessment is carried out by European Food Safety Authority (EFSA).
The Novel Food status Catalogue may be used to check if a food needs a pre-market authorisation.
See also
Genetically Modified Organisms (GMOs)
If your products involve the use of genetically modified organisms (GMOs), understanding EU rules is critical for market access and compliance.
Genetically modified food and feed
If your food or feed product contains, consists of or is produced from GMOs, it must be authorised for sale or for cultivation in the EU.
- Application preparation: you must submit a scientific dossier demonstrating product safety and provide a detection method. The European Food Safety Authority (EFSA) tools and guidance can help applicants including SMEs in this process.
- Submission and assessment: the application must be submitted to the national competent authority. EFSA evaluates your application as regards safety aspects. Approved products receive EU-wide authorisation and are listed in the GMO register.
Deliberate release of GMOs into the environment
- Market release: products other than food and feed containing or consisting of GMOs that are intended for the European market or for cultivation require EU authorisation. An application must be submitted to the national competent authority. This authorisation is valid in all EU countries and is listed in the GMO register.
- Release for non-marketing purpose (e.g. field trials): the deliberate release of GMOs into the environment for non-marketing purposes also requires approval. You must notify your national competent authority if you wish to conduct a release for research or other non-marketing purposes. Public registers of such notifications ensure transparency.
Contained use of GM micro-organisms (GMMs)
For laboratory or facility use:
- Notification: depending on the risk of the contained use, notify or get approval from your national competent authority before starting.
- Scope: EU rules apply to GMMs but not GM plants or animals (some EU countries may have separate national rules to cover the latter).
See also
EU directive on deliberate release of GMOs
Pesticides
If you are developing alternatives to synthetic pesticides, like micro-organisms, semiochemicals, peptides, or iRNA, here’s what you need to know:
- Micro-organisms as active substances in pesticides: these are a key sustainable option and can also be used in organic farming. EU rules streamline authorisation for products containing them.
- Other emerging alternatives: substances like semiochemicals (e.g. pheromones), plant extracts, and peptides are gaining traction. EU guidance explains and simplifies authorisation for these innovations.
- EU pesticide guidance database: a dedicated database of test methods and guidance documents can help SMEs prepare applications.
Before a plant protection product can be authorised in a Member State, all the active substances it contains need to be approved at EU level. A scientific evaluation on the dossier with safety and efficacy data ensures your product is safe for health and the environment.
See also
EFSA support and resources
The European Food Safety Authority (EFSA) provides tools and guidance that can help applicants. Examples of guidance include:
- GMO applications: regulations and guidance
- Feed additive applications
- Guidance on the characterisation of microorganisms used as feed additives or as production organisms
- Pesticide evaluations: regulations and guidance
- Novel and traditional food applications and notifications: regulations and guidance
- EFSA pesticide webpage
- EFSA also has special services for SMEs, such as fast processing of web form queries.
Intellectual property
For biotech or biomanufacturing SMEs and startups, securing intellectual property (IP) protection is essential for growth, attracting investment, and protecting your innovations. There is a range of resources, tools, and guidelines to help you navigate IP protection.
Patent protection for biotech inventions
Biotech developers should be aware that EU rules as well as the European Patent Convention specify what can and cannot be patented, especially for ethically sensitive inventions (such as those involving human genetic modification).
The European Patent Office (EPO) provides specific guidance for biotech patents, including dedicated resources and patenting advice for biotechnological innovations. Consult the EPO’s resources on biotech patenting to see if your invention qualifies. Doing this early will prevent wasted time and costs on non-patentable ideas and ensure compliance with EU ethical standards.
Biotech innovators can also benefit from the unitary patent which offers uniform protection in 18 participating EU countries on a one-stop-shop
basis, providing huge cost advantages and reducing administrative burden.
For new pharmaceutical and agrochemical products requiring marketing authorisation,
EU rules provide for a possibility to obtain a supplementary protection certificate (SPC), which extends, for up to 5 years, the protection of that product by a patent.
Find out more about your patent rights.
Special protection for plant varieties
The Community Plant Variety Office (CPVO) offers IP rights for new plant varieties, protecting your agricultural innovations throughout the EU.
Plant variety rights give your biotech startup exclusive control over your plant varieties, preventing unauthorised use or reproduction. If your company is innovating in plant breeding, apply for plant variety rights through CPVO to protect your unique varieties across the EU.
Find research and technology infrastructures
If you are developing innovative products, research infrastructures, such as European Research Infrastructure Consortiums (ERICs), can help your SME or start-up innovate and grow in the EU market, de-risk investments, accelerate innovation, and facilitate technology deployment.
Research Infrastructures are facilities that provide resources and services to conduct research and foster innovation in their fields, including the associated human resources, major equipment or sets of instruments, computing systems, communication networks and any other essential infrastructure.
The specific services provided by research and technology infrastructures include:
- access to scientific instrumentation and research and testing facilities
- generation, curation, storage and access to data
- research and development services, including those generating IP
- technology services and associated business development support
- testing and validation of specific technologies, solutions or industrial processes
- demonstration or piloting of new technology or production processes
- checking and testing for sustainability, regulatory compliance, safety validation, etc.
- provision of education and/or training in new technologies
If you are interested in accessing or collaborating with biotech research and technology infrastructures, first identify those that best fit your needs. Some receive Horizon Europe support to offer free translational access. Contact the infrastructure and explore access conditions.
Key research and technology infrastructures and resources
European Strategy Forum on Research Infrastructures (ESFRI)
ESFRI is a strategic instrument to develop the scientific integration of Europe and to strengthen its international outreach. It has a portfolio of top-tier research infrastructures in Europe which enable:
- Access to specialised facilities (e.g., advanced testing and data analysis)
- Networking opportunities with leading research organisations
- Tailored support for advanced R&D areas like drug development and genetic research.
The EOSC initiative aims to create a unified data-sharing environment for researchers. It facilitates collaborative access to diverse datasets across scientific domains, promoting open science principles.
European Association of Research and Technology Organisations (EARTO)
Research and Technology Organizations (RTOs) drive innovation by developing, testing, and validating new technologies and processes across all scientific fields, including biotechnology and biomanufacturing. As non-profits, their mission is to bridge knowledge, skills, and infrastructure to deliver collaborative R&D with public and industrial partners of all sizes.
Research and Technology Infrastructures in Europe (RITIFI): The RITIFI consortium, composed of research infrastructures (RIs) and technology infrastructure stakeholders (TIs) from 10 European countries, aims to improve the integration and structure of the European R&I landscape. It does so by developing a functional framework for the integration of RI and TI services tailored to the needs of end-users.
ERA-Net Cofund on BioTechnologies
The ERA-NET Co-fund on Biotechnologies (ERA CoBioTech) is a project that promotes synthetic biology and systems biology to drive industrial biotechnology. Key services include:
- Funding opportunities: Grants for biotech SMEs to support R&D and innovation projects.
- Cross-border collaboration: Opportunities for biotech companies to participate in cross-national projects.
- Technology scale-up support: Assistance for scaling technologies from lab to market.
European Monitor of Industrial Ecosystems - Technology Centres
The European Monitor of Industrial Ecosystems can help you gain insights into market trends, technological advancements, and other opportunities. EMI also maps around 50 biotech-focused technology centres across Europe that provide R&D support, mentoring, and product development expertise.
- Access to technology expertise and facilities for validation
- Demonstration
- Proof of concept / lab testing, prototype development
- Pilot production and Product validation / certification
Multidisciplinary life science infrastructures
Some infrastructures offer highly specialised resources that are directly relevant to biotech companies, each with unique expertise areas:
- INFRAFRONTIER: provides model organisms for biomedical research and drug development.
- BBMRI-ERIC: access to biobanks, essential for epidemiology and personalized medicine.
- ELIXIR: access to biological data and bioinformatics resources for research in health, genomics and biotechnology.
- Euro-BioImaging ERIC: advanced imaging techniques in biological and biomedical research and cutting-edge imaging facilities.
Infrastructures for specific biotech applications
For biotech projects with unique requirements, explore these targeted resources that offer specialised expertise and facilities across Europe:
- IBISBA: multidisciplinary, integrated services to accelerate end-to-end bioprocess development for health, pharmaceuticals, and sustainable development, focusing on bioprocess innovation.
- EMBRC-ERIC: marine biological resources for ecological and health-related research.
- ERINHA: high-risk pathogen research, in vitro and in vivo, on emerging infectious diseases.
- EU-OPENSCREEN ERIC: access to screening libraries and chemical biology expertise, supporting early stages of drug discovery by enabling the identification of bioactive compounds.
Infrastructures for translational and industrial support
Translational and industrial support infrastructures are vital for biotech companies, helping turn research into real products. They offer advanced facilities, expert guidance, and testing environments, reducing risks and speeding up development. This support can help you innovate faster and bring solutions to market efficiently.
European Clinical Research Infrastructure Network (ECRIN)
Supports multinational clinical research in Europe with services, tools, and expert consultation to facilitate large-scale clinical studies. It also offers access to its Trial Management Tool and Data Centre Certification Program to ensure the reliability and reproducibility of clinical trial results.
EATRIS (European Infrastructure for Translational Medicine)
EATRIS supports translational medicine by connecting academic research with industry. It enhances the development of new therapies through collaboration and resource sharing among research institutions and the healthcare industry.
Microbial Resource Research Infrastructure - ERIC (MIRRI-ERIC)
MIRRI-ERIC brings together 50+ microbial domain Biological Resource Centres (mBRCs), culture collections and research institutes from ten European countries. It focuses on microbial resources, providing access to collections of microorganisms and associated data, supporting research in various fields such as biotechnology, health, and agriculture. This centre enhances the understanding of microbial biodiversity and its applications in research and industry.
Scaling up your business
Scaling up your biotech or biomanufacturing business means building the connections, expertise, and tools needed to expand operations, access new markets, and achieve sustainable growth. The EU provides a variety of resources to help SMEs in biotech or biomanufacturing succeed.
Scaling up: 'lab to fab'
The following tools and projects may help you to bring your innovations from a small-scale laboratory environment to an industrial scale:
- Pilots4U: maps all existing open access pilot and demo-infrastructures across Europe and creates an easily accessible network.
- InvestEU Advisory Hub: helps biotech companies in reviewing and designing the business/financial model.
- SCALE-UP: helps businesses identify and scale-up innovative and sustainable bio-based value chains that build on regional resources.
- MainstreamBIO: offers digital tools to get small-scale bio-based solutions into mainstream practice across rural Europe.
- Technology Centre Mapping | European Monitor of Industrial Ecosystems: gain insights into market trends, technological advancements, and opportunities. EMI also maps around 50 biotech-focused technology centres across Europe that provide R&D support, mentoring, and product development expertise.
Insights and expertise for growth
Expand your knowledge base and leverage EU-backed data-sharing platforms, strategic insights, and expertise to drive innovation and collaboration:
- European Monitor for Industrial Ecosystems (EMI): gain insights into market trends, technological advancements, and opportunities. EMI also maps around 50 biotech-focused technology centres across Europe that provide R&D support, mentoring, and product development expertise.
- Open science and data collaboration: platforms like the European Open Science Cloud (EOSC) and the European Health Data Space (EHDS) enable biotech researchers to access shared datasets across the EU, boosting collaboration in fields like epidemiology and personalised medicine.
- Policy and market insights: resources like CORDIS and the EU Science Hub offer data, reports, and strategic insights on EU biotech policies, market trends, and funding opportunities.
Access to markets
Scaling biotech companies need clear pathways to enter local, EU, and global markets. This involves understanding regulatory frameworks, identifying distribution partners, and leveraging networks to increase market visibility.
- Enterprise Europe Network (EEN): EEN helps you with personalised services free of charge to innovate, finance, and expand your business into new markets, get funding and connect with partners in more than 60 countries.
- EU Access2Markets Database: For international market entry, check tariffs, regulatory requirements, and trade barriers using the EU’s database.
Business support
Build strategic connections with industry leaders, researchers, and public authorities to foster partnerships, share expertise, and unlock growth opportunities for your biotech business.
Networking and collaboration
- Enterprise Europe Network (EEN): connect with business and innovation partners worldwide. EEN offers tailored advice on expanding internationally, finding funding, and meeting regulatory requirements.
- European Cluster Collaboration Platform (ECCP): ECCP supports regional networks of businesses, research institutions, and other stakeholders that drive innovation and competitiveness in specific industries. These clusters help SMEs with access to innovation, networking and partnerships, shared resources and expertise, increased competitiveness, easier access to funding and support. More than 1500 clusters are listed, of which around 90 in biotech.
- Regional Innovation Valleys (RIVs): these initiatives connect regional innovation ecosystems across Europe, helping biotech SMEs collaborate with academic institutions, industry leaders, and public authorities. RIVs aim to accelerate innovation, particularly in key areas like health, green technologies, and digital transformation. Check the RIV Match Making Map for potential partners or consult local authorities.
Finance and funding support
Use the resources, portals, and EU programmes below to find funding and support for research, development, and commercialisation activities for your biotech business across the EU.
Simplified access to EU funding
Access to EU Finance provides an entry point for biotech companies seeking EU funding. It offers information on funding sources in the EU, including grants, loans, microfinance and equity options.
The STEP Portal consolidates all EU funding opportunities for biotechnologies and other critical technologies supported by the Strategic Technologies for Europe Platform (STEP).
The Funding & Tenders Portal centralises applications for EU-funded programs. Use it to search for the biotech or biomanufacturing related projects in the grants and funding section below.
Grants and funding opportunities
- Horizon Europe is the EU’s key funding programme for research and innovation. It funds biotechnology and biomanufacturing through R&I projects driven by scientific opportunities.
- The European Innovation Council (EIC) supports biotech projects through grants, equity, and financing from multiple sources (also known as blended finance) for SMEs and start-ups.
- HERA Invest supports biotech research and development for health emergencies relevant to companies working in infectious diseases, vaccines, and diagnostics.
- The Innovative Health Initiative (IHI JU) is a public-private partnership that funds large-scale collaborations focused on health innovation, including biotech R&D in drug discovery and precision medicine.
- The Circular Bio-based Europe Joint Undertaking (CBE JU) funds projects advancing competitive circular bio-based industries. It accelerates the innovation of bio-based solutions, their market deployment, and the environmental performance of bio-based industrial systems.
- Processes4Planet (P4Planet) is an initiative that funds biotech projects in sustainable process industries, aiming to support EU Green Deal goals with bio-based manufacturing and bioprocessing solutions.
- The LIFE Programme funds environmental and climate action initiatives across the EU. LIFE is relevant for biotech and biomanufacturing projects in areas like sustainable production, environmental impact reduction, and bio-based economy solutions.
- The Innovation Fund supports biotech and industrial projects aimed at reducing carbon emissions.
- The EU4Health Programme (EU4H) is a program aimed at improving public health across Europe by funding projects that address health inequalities, enhance disease prevention, and strengthen health systems.
- The Digital Europe Programme funds biotech innovations that integrate digital solutions.
- The European Defence Fund (EDF) finances research on defence technology and technology with benefits both for civil and defence applications (‘dual-use technology’). It notably supports actions linked to “disruptive technologies based on concepts or ideas originating from “non-traditional defence’s state-of-art,” including biotechnologies.
Loans, guarantees and venture capital
- The European Investment Bank (EIB) and European Investment Fund (EIF) offer loans, guarantees, and venture capital support for biotech companies, targeting high-risk, high-potential projects in health, green technology, and innovation.
- InvestEU offers financing and advisory services targeting high-risk, high-potential projects in health, green technology and innovation. The EUinvest portal proposes services to match company needs and financing offer and provides a single EU-wide database of investment opportunities.
- The InvestEU Advisory Hub helps projects reach the financing stage.
Regional and skill development funding
- The European Regional Development Fund (ERDF) funds research clusters, infrastructure, and biotech start-ups in underdeveloped regions.
- The European Social Fund (ESF) provides support for training and skill development in biotech, promoting workforce growth and regional economic resilience.
- The Interregional Innovation Investments Instrument (I3) fosters interregional collaboration in innovation, supporting regions to invest in areas like biotech
Sector specific and strategic technology funding
- The EIC Corporate Partnership Programme connects biotech innovators with corporate partners.
- The Made in Europe Partnership promotes digital and sustainable innovation in manufacturing.
- The European Institute of Innovation and Technology (EIT) offers biotech companies targeted support through funding calls that finance innovation projects, accelerate startup growth, and provide valuable educational resources in health, food and manufacturing.