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:
Learn more about how EMA interacts with academia.
Featured information for academics and researchers
Report on EMA-HMA medicine repurposing pilot
A report is available on a pilot that provided tailored scientific advice to not-for-profit organisations and academics on repurposing authorised medicines for new indications. The report contains findings and recommendations from the pilot. EMA and Heads of Medicines Agencies (HMA) carried out this pilot between 2021 and 2024.
EMA communication activities: 2024 survey results
We asked stakeholders for feedback on our external communication activities via a bi-annual survey disseminated in May 2024. The results are available in a newly-published report. They help us to establish baselines and targets to measure progress, analyse trends and address areas for improvement.
EMA publishes reflection paper on submission of single-arm clinical trials in marketing authorisation applications
This reflection paper provides considerations for medicine developers on establishing efficacy based on single-arm clinical trials submitted as pivotal evidence in a marketing authorisation applications. EMA's Methodology Working Party finalised this document. CHMP adopted it in September 2024.
Paediatric applications moved to IRIS platform
From 4 June 2024, the IRIS platform will provide a secure online environment for applicants to submit and manage their paediatric medicines applications and related documents. The previous submission process only applies for ongoing applications submitted before 4 June. With IRIS, applicants can check the status of their applications and get automatic updates from any device. IRIS simplifies interaction with EMA, improves data quality, transparency and efficiency in the paediatric application process.
EMA joins EU Partnership on Animal Health and Welfare
EMA has become an associate of the EU Partnership on Animal Health and Welfare, established to help control infectious diseases of both terrestrial and aquatic animals. This partnership also aims to support the global One Health initiative. In this capacity, EMA will strengthen links between research and EU medicines regulation through communication and engagement with researchers and other stakeholders.
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.
Latest news
Campaign highlights how different actors can help in case of a shortage
PRAC agrees on a communication to healthcare professionals on injectable tranexamic acid medicines
Two new medicines recommended for approval; another eight medicines recommended for extension of their therapeutic indications
Higher rate of death and disease complications in recent trials means benefit-risk balance no longer favourable
Publications of interest
EMA's 2023 annual report
Navigate through the digital report to view interviews, short videos and an interactive timeline of the Agency’s main activities in 2023. Read the traditional PDF version to see additional figures and statistics on EMA's regulatory procedures and activities.
Video: Working for every patient in Europe
Watch our short video for a quick and easy explanation of who EMA is and what it does. (video in English, with subtitles in 24 different languages).