Subtitle 1: Strategic Combination of EIC Funding and EMA Regulatory Expertise

The European Medicines Agency (EMA) and the European Innovation Council and SME Executive Agency (EISMEA) have signed a joint Rolling Work Programme 2026-2027 on July 15, 2026, to enhance support for health innovation. This agreement formalizes a collaborative framework that has been in place on a pilot basis since 2021, aiming to reduce barriers to market entry for health and healthcare startups. It ensures that early-stage ventures receiving funding from the European Innovation Council (EIC), with a total budget of EUR 10.1 billion, receive tailored guidance from regulatory agencies from the development planning stage. Ultimately, this strategic objective aims to proactively prevent development risks arising from regulatory non-compliance in the capital-intensive process of new drug development.

Subtitle 2: Reducing New Drug Development Costs by Enhancing Regulatory Preparedness

Biotech startups often possess excellent basic scientific research results but face delays in obtaining approval for their Investigational New Drug (IND) applications due to a lack of understanding of complex European regulatory guidelines. To address this bottleneck, the two agencies provide customized Regulatory Readiness consulting to companies supported by the EIC Accelerator and Pathfinder programs. This program proactively maps out the required toxicity assessment criteria and Good Manufacturing Practice (GMP) design guidelines from the preclinical animal testing stage. By establishing a regulatory compliance roadmap from the early stages, the time required to transition from preclinical to Phase 1 and Phase 2 clinical trials can be shortened, and unnecessary retesting costs can be significantly reduced.

Subtitle 3: Activating Horizon Scanning for Securing Future Technologies

To proactively address disruptive technologies with high unmet medical needs, the two agencies are launching a joint Horizon Scanning initiative. This aims to monitor and predict advanced health technologies that are difficult to accommodate within existing regulatory frameworks, such as gene therapy, regenerative medicine, and AI-based digital therapeutics (DTx). By analyzing the scientific principles of new technologies in advance, regulatory agencies can establish new evaluation guidelines in a timely manner, minimizing regulatory gaps. Innovative companies can also avoid delays in approval at the time of technology development, maximizing their market exclusivity period.

Subtitle 4: Fostering a European Ecosystem in Response to the ARPA-H Initiative

This collaboration also has a political and economic background, aiming to protect Europe's leading position in the health industry in response to the United States, which dominates global biotech investment and provides regulatory support through the FDA. The United States is investing trillions of won in health budgets through the Advanced Research Projects Agency for Health (ARPA-H) and actively supporting the regulatory approval of startups. The European Union is also actively reducing regulatory barriers to prevent its innovative drug candidates and medical devices from being diverted to the United States or Asian markets due to complex European approval procedures. As a result, excellent innovative biotech companies are expected to remain in Europe, forming a self-sustaining ecosystem and providing the most advanced treatment options to European patients in a virtuous cycle.