ODD grants up to 10 years of market exclusivity upon approval, safeguarding investments and fostering a competitive advantage. (EMA, 2023)
The EMA significantly reduces regulatory fees for ODD-designated therapies, easing the financial burden on smaller companies and startups. (EMA, 2023)
The EMA provides scientific advice and protocol assistance, offering expert guidance on clinical trial design and regulatory strategy. (EMA, 2023)
In certain cases, promising early-stage data can lead to conditional approval, accelerating patient access while the company gathers additional evidence. (EMA, 2023)
Attracting Investment
A positive regulatory outcome in Europe and a successful market launch can attract significant investment from global investors. This influx of capital can fuel further research, development, and commercialization efforts, including expansion into other markets like the US.
Generating Robust Evidence
The EMA places a strong emphasis on real-world evidence (RWE) generation, including patient reported outcomes (PROs) and quality-of-life data. This focus aligns with the growing demands of global payers and health technology assessment (HTA) bodies, strengthening the therapy’s value proposition worldwide. (Eurordis, 2022)
Partner Rare is a team of seasoned experts with a deep understanding of the European rare disease ecosystem. We offer comprehensive support throughout the development and commercialization journey, helping you navigate the EMA’s regulatory landscape, design and execute clinical trials, and develop effective market access strategies.
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Conclusion
Europe’s commitment to rare disease innovation, coupled with the EMA’s supportive regulatory framework, presents a unique opportunity for companies developing rare disease therapies. By partnering with experienced consultants like Partner Rare, you can leverage this opportunity to accelerate your therapy’s global impact and ultimately bring life-changing treatments to patients worldwide.
If you are ready to unlock the vast potential of Europe for your rare disease therapy, contact Partner Rare today to schedule a meeting.
Let’s discuss your specific development and commercialization goals and explore how our expertise can propel your therapy towards success.
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