EMA and EU Innovation Agency Deepen Ties to Speed Up Drug Development

The European Medicines Agency (EMA) announced on July 15, 2026 that it has strengthened its relationship with the European Innovation Council and SMEs Executive Agency (EISMEA) to help early-stage biopharmaceutical and medical technology developers engage with European Union regulatory requirements earlier in the drug development process.1 EMA’s Executive Director, Emer Cooke, and EISMEA’s Director, Momchil Sabev, signed a letter of intent formalizing a relationship the 2 organizations have maintained since 2021. The agreement is paired with a rolling work program for 2026–2027 that turns shared goals into specific joint activities.

EISMEA administers the European Innovation Council, which funds high-risk, high-potential research across the EU, including biotechnology and health technology projects. Since the two organizations began working together, their joint efforts have focused on helping innovators move early-stage research toward medicines and health technologies that satisfy European regulatory standards.

What the Partnership Means for Drug Developers

The reinforced agreement targets small and medium-sized enterprises, start-ups, spin-offs, research organizations, and universities with training, awareness campaigns, outreach, and support services designed to clarify regulatory expectations earlier in a product's development.

“Enabling innovation is central to our public health mission to bring new treatments to patients,” Cooke said in a press release.1 “Our collaboration with EISMEA helps us better support innovators to address unmet medical needs, improve health outcomes and strengthen Europe's competitiveness.”

According to Sabev, early regulatory engagement changes how innovators plan their development programs.

“The earlier health innovators can engage with regulatory expertise, the better equipped they are to make informed development decisions, reduce risk and achieve our shared objective: to get innovative solutions to patients,” Sabev said in the press release. “This partnership is another step in creating the conditions that allow Europe's most promising companies to succeed.”

Going forward, the 2 organizations plan to continue regulatory-readiness work for emerging health technologies, support projects funded by the European Innovation Council, and expand training, education, and stakeholder engagement activities aimed at improving understanding of the regulatory framework among funded innovators.

The agencies point to early results from their existing collaboration. According to a joint feedback survey, three-quarters of European Innovation Council-funded innovators said their awareness of the EMA’s support tools increased after participating in joint training activities. Respondents said the tools had a positive effect on both product development and regulatory strategy, and 95% said they would use them again for future projects.

Why This Matters for Pharmaceutical Manufacturers

For manufacturers, particularly smaller biopharmaceutical and medical technology companies without dedicated regulatory affairs teams, earlier access to regulatory guidance may reduce the risk of late-stage surprises tied to chemistry, manufacturing, and controls requirements. Complex modalities such as cell and gene therapies, personalized medicines, and products that combine drugs with digital or artificial intelligence components often carry manufacturing and quality considerations that are difficult to retrofit once a development program is already underway.

By connecting funded innovators with regulatory expertise before pivotal studies and scale-up decisions, the partnership could help smaller developers build manufacturing and quality strategies that align with European expectations from the outset, rather than adjusting them after regulatory feedback arrives late in development. That alignment matters for an industry increasingly focused on advanced therapies and novel manufacturing platforms, where regulatory and manufacturing complexity tend to compound each other.

The initiative also reflects a broader push within European Union pharmaceutical policy to support smaller developers, a priority also visible in the ongoing overhaul of the bloc's pharmaceutical legislation and in proposals for regulatory sandboxes covering advanced therapies, digital health tools, and novel antimicrobials.2-4

References

1. EMA and EISMEA boost cooperation to accelerate health innovations. Press release. EMA. July 15, 2026. https://www.ema.europa.eu/en/news/ema-eismea-boost-cooperation-accelerate-health-innovations
2. EMA welcomes political agreement on new EU pharmaceutical legislation. Press release. EMA. December 11, 2025. Accessed July 15, 2026. https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation
3. EU overhauls pharmaceutical law with sweeping 2026 reform package. Osborne Clarke. March 31, 2026. Accessed July 15, 2026. https://www.osborneclarke.com/insights/eu-overhauls-pharmaceutical-law-sweeping-2026-reform-package
4. Haigney S. EMA calls new EU pharma legislation most significant in two decades. PharmTech.com. December 12, 2025. https://www.pharmtech.com/view/ema-calls-new-eu-pharma-legislation-most-significant-in-two-decades