EU’s New Plan to Supercharge Biotech Innovation

What's the problem that is being addressed

The European Union has excellent biotechnology research but struggles to turn scientific discoveries into commercial products and manufacturing at scale. Despite world-class science (with publication records matching the US and China), EU biotech companies face major challenges:

• Limited funding: US biopharma startups received about 9 times more late-stage funding than EU startups (€219 billion in the US versus €25 billion in the EU between 2015 and June 2025)
• Slow regulatory processes: Clinical trial approvals in the EU take an average of 113 days for multinational trials, compared to 60 days in competing regions
• Fragmented rules across EU countries that create extra costs and delays
• Skills shortages in key areas like research, regulatory affairs, and data analysis
• Underused manufacturing capacity, especially for important products like biosimilars
• Difficulty attracting and keeping biotech companies in Europe—they often move operations abroad for better funding and faster approvals

What changes as a result of this document

This regulation (called the European Biotech Act) creates a simpler, faster system to help biotech innovations reach patients and the market:

• Recognizes special "health biotechnology strategic projects" that get priority treatment, faster permits (8-10 months maximum), and dedicated support
• Sets up an EU-wide support network to help companies—especially small businesses—navigate regulations and find funding
• Launches an EU investment pilot with the European Investment Bank to bring more capital to biotech companies at all development stages
• Speeds up clinical trial approvals: multinational trials will be approved in 75 days (down from 106 days), with some trials approved in just 47 days when no extra information is needed
• Creates testing environments ("regulatory sandboxes") where companies can safely test new approaches under supervision
• Provides 12 extra months of patent protection for certain innovative biotech medicines developed and manufactured in the EU
• Strengthens EU manufacturing of biosimilars (copycat versions of expensive biological medicines) to improve access and lower costs
• Establishes clear rules to prevent misuse of biotechnologies while still encouraging innovation
• Simplifies food safety rules to speed up approval of biotech food innovations

How that problem is being solved here

The regulation tackles the funding gap by connecting EU biotech companies with investors through a new investment pilot program. It cuts red tape by harmonizing rules across EU countries and creating single contact points to guide companies through permits and approvals. For clinical trials—the essential step before medicines reach patients—the regulation gives one country a stronger leading role in assessments, reducing duplicate work and speeding decisions. It also helps small companies by providing free guidance on study design before they submit applications, reducing delays caused by incomplete paperwork. The regulation balances innovation with safety by keeping all current health and environmental protections while making the path to market clearer and faster. It specifically focuses on health biotechnology first (covering human medicines, veterinary products, and related areas), with plans to address other biotech areas in 2026.