Academia

On this page, you will find information on the European Medicines Agency’s (EMA) activities that are most relevant to academia, including news and events. Learn more about the Agency's resources to support medicine development:

Human regulatory: Research and development
Veterinary regulatory: Research and development

Learn more about how EMA interacts with academia.

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  Promoting a One Health approach in Europe

  EMA and other scientific EU agencies responsible for human, animal health and environmental protection have issued a joint statement on promoting a joined-up One Health agenda in Europe. They identify four priority areas for action.

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  Bacteriophages as veterinary medicines: guideline now available

  A CVMP guideline is available on the quality, safety and efficacy of bacteriophages as veterinary medicines. These viruses that infect bacteria could substitute or complement the use of antibiotics in animals. The guideline sets out the regulatory and scientific requirements for veterinary medicines designed for phage therapy and composed of bacteriophages.

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  EMA communication activities

  We asked stakeholders for feedback on our communication activities in a survey in 2022 and captured the results in a newly-published report. The findings help us set targets, address areas for improvement and measure progress. For example, we are already adapting our messaging to better suit audience needs and are creating more visuals based on survey insights. We thank all respondents for their feedback.

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  New online platform for PRIME eligibility requests

  As of 10 July 2023, medicine developers should use EMA’s IRIS platform to submit a PRIME eligibility request. Guidance is available on how to register for IRIS and use it for PRIME eligibility requests and other procedures.

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  Public consultation on integrating real-world evidence into regulatory decision-making

  EMA is inviting comments on ICH’s reflection paper on integrating real-world evidence into regulatory decision-making. It concerns the harmonisation of terminology and convergence of general principles for planning and reporting studies using real-world data. Provide your feedback by 30 September 2023.

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  Survey on essential substances for the treatment of equine species

  EMA is inviting veterinarians, academics and relevant experts to assist the Agency in formulating a scientific opinion to update the European Union (EU) list of essential substances for the treatment of equine species. Please complete EMA’s survey by 30 June 2023 to contribute to this exercise.

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  Call for clinical-oncology scientists to join EMA / HMA pilot on participation in medicine regulation

  EMA and HMA are inviting clinical-oncology and haemato-oncology scientists to apply for a pilot project aiming to develop their expertise in human medicine regulation. The pilot offers free webinars providing an understanding of the basic principles for this field. Participation is possible until May 2024.

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  Engaging with academia: action plan for 2021 to 2023

  EMA's academia collaboration matrix action plan sets out how EMA intends to create closer ties with academics and researchers in the next two and a half years. It lists actions in five areas: regulatory science and partnerships, innovation and support to academia, communication, events strategy, and training.

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  European medicines agencies network strategy to 2025

  The strategy sets out how the network will continue to enable the supply of safe and effective medicines, in the face of developments in science, medicine, digital technologies, globalisation and emerging health threats, such as the COVID-19 pandemic.

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  Fee waiver for protocol assistance (scientific advice for orphan medicines)

  Applicants from the academic sector can receive free protocol assistance for developing orphan medicines.

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