The European Medicines Agency (EMA) is launching a new initiative starting in January 2025 to support impactful public health research by waiving fees for Scientific Advice. This opportunity is available to eligible non-profit organisations classified as “Entities Not Engaged in an Economic Activity.”
This programme aims to provide academic and non-commercial research projects with limited funding access to expert regulatory guidance, fostering innovation and ensuring alignment with public health priorities.
Eligibility Criteria
To qualify for the fee waiver, organisations must meet the following conditions:
- It must be non-profit or legally obligated not to share profits with owners, shareholders, or members.
- It cannot be owned, controlled by, or have agreements with any private profit-making organization (PPO) for sponsoring or participating in the specific research project.
- It must be located in the European Economic Area (EEA).
Applicants are required to provide supporting documents, such as founding statutes and a formal declaration confirming no ties to PPOs.
Application Requirements
Applicants must also explain how the advice they seek will positively impact their research and contribute to public health priorities. They should include details such as:
- The public health problem being addressed.
- Lack of funding to cover regulatory fees.
- Key aspects of their clinical trials, including multinational efforts.
- How their work supports future medicine approvals or develops tools to improve regulatory science and medicine evaluation.
By focusing on projects with significant public health benefits, the EMA ensures that its support is directed where it is most needed.
👉 Learn more about the eligibility criteria and how to apply here.
This fee waiver is a fantastic opportunity for academic and non-commercial researchers to advance their work while benefiting from the EMA’s expert advice. Don’t miss out!
