Your gateway to biotech and biomanufacturing innovation in the EU
The biotech and biomanufacturing sectors are at the forefront of innovation, shaping industries from healthcare to food production and chemicals. For SMEs and startups in this dynamic field, understanding the regulatory landscape, accessing research infrastructures, and scaling up operations can be challenging. This is where the Biotech and Biomanufacturing Hub on Your Europe can help – with resources on how to bring groundbreaking ideas to life – from securing market authorisation to accessing funding and expertise.?
Bring your biotech solution to the market?
Launching a biotech innovation in the EU involves navigating important rules and meeting high standards. These steps ensure your product is safe, effective, and ready for market use. If you're working on medicines or medical devices for human use,? Your Europe connects you with essential resources to:?
Medicines for animal use must also undergo rigorous evaluation to ensure safety and efficacy, while supporting public health and environment. Like human medicines, veterinary medicines can be authorised via EMA or national authorities. For veterinary medicines used in food-producing animals (such as meat or dairy), the additional requirement in EU regulations to set maximum residue limits apply to ensure consumer safety. Clinical trials are regulated at the national level in each EU country, but there are guidelines available for multicentre/multinational trials that can help streamline the process. For SMEs, EMA provides the same support services as for the human medicines.?
For businesses working on biotech agri-food solutions, the EU also provides clear pathways to ensure compliance. For example, all food improvement agents such as additives and enzymes are subject to a common authorisation procedure.??
When it comes to genetically modified organisms (GMOs), they must be authorised for sale or cultivation in the EU. The European Food Safety Authority (EFSA) provides scientific evaluations and can help SMEs with the application process.?
The Biotech and Biomanufacturing Hub unites in one place all the relevant information on the rules you need to follow.??
Accelerate your innovation with EU infrastructure?
For biotech startups and SMEs, having access to the right facilities, tools, and expertise can make the difference between an idea and a breakthrough. Across the EU, specialised research infrastructures are available to support innovation, reduce risks, and accelerate the journey from lab to market. These resources can help you design, test, and refine your biotech solutions while ensuring compliance with industry standards. The Hub provides a comprehensive list of these infrastructures, so you can easily navigate and decide which one suits your needs best.??
If you're unsure where to start, platforms like the European Strategy Forum on Research Infrastructures (ESFRI) and the European Monitor of Industrial Ecosystems (EMI) can help you identify the right infrastructures for your research goals, connect with experts, and take advantage of funding and support programmes.?
When you are ready to move from research to application, EU infrastructures can bridge the gap between the lab and the market. For example, EATRIS connects biotech developers with translational medicine resources to speed up the development of therapies, while ECRIN provides tools and support for conducting multinational clinical trials, ensuring compliance with EU standards.?
For companies working on unique biotech projects, there are targeted infrastructures designed to address application-specific needs, which allow you to test, validate, and refine your biotech innovations in specialised environments. Some multidisciplinary hubs offer highly specialised facilities and expertise for projects with unique requirements, such as drug development or personalised medicine. Visit Your Europe to discover all the facilities that can support your research or startup, whether you need expert advice, major equipment, computing systems or any other infrastructure.?
?Scale up your business with EU support?
Taking your biotech business to the next level requires the right tools, connections, and funding. The EU offers extensive support to help companies scale up their operations, access new markets, and achieve sustainable growth. From transforming your laboratory research into industrial solutions to navigating funding opportunities, the Hub on Your Europe provides a step-by-step breakdown on how to succeed.?
Transitioning from small-scale research to large-scale manufacturing is a critical step for biotech and biomanufacturing companies. The EU is funding projects that make this process more efficient and accessible, such as the Pilots4U network of open-access pilot and demo facilities across Europe for testing and scaling up production processes. Breaking into new, complex markets can be streamlined with help from the Enterprise Europe Network (EEN), which offers personalised advice on expanding internationally, innovating, partnering and much more in over 60 countries.?
Tools like CORDIS and the EU Science Hub provide insights into biotech trends, EU policies, and funding opportunities to drive your business forward. Strong networks are the backbone of growth that can also unlock new opportunities and drive innovation and competitiveness. One example is the European Cluster Collaboration Platform (ECCP), which connects biotech SMEs with over 1,500 clusters, including 90 in biotech, offering access to shared resources, funding, and expertise.?
Funding is often one of the biggest barriers to scaling up businesses. The EU offers a range of funding opportunities tailored to biotech companies, from research and innovation grants from Horizon Europe to loans and guarantees from the European Investment Bank (EIB). But scaling up isn't just about funding facilities – it's also about people. The EU invests in workforce development through programmes such as the European Social Fund (ESF), which supports skills development and training for biotech professionals. Additionally, the European Regional Development Fund (ERDF) supports innovation in underdeveloped regions, helping SMEs build resilient and capable teams.?
Navigate the EU biotech and biomanufacturing sphere with Your Europe?
The journey from an idea to a market-ready solution can be particularly complex in the biotech and biomanufacturing sectors, but with the right resources and support, you can navigate regulatory pathways, access world-class infrastructure, and scale up your business with confidence.?
Visit Your Europe today and discover how the hub will unlock your company’s full potential and take the next step in shaping a more innovative future!?