EMA event supporting materials
EMA has selected this series of key materials for attendees of DIA and BIO to have quick access to information about how EMA works and its recent initiatives.
Italian is available via eTranslation, the European Commission's machine translation service.
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EMA's role in medicines regulation across the EU
Check our interactive timeline to learn about each stage a medicine goes through from initial research to patient access, and about how EMA supports medicine development, assesses the benefits and risks of medicines and monitors their safety.
To find out more, see:
Annual report on EMA's activities in 2025
Explore our Digital annual report 2025 to learn about EMA's activities during 2025.
EMA's responsibilities in overseeing clinical trials
Learn about the Clinical Trials Regulation, including how it overhauled the oversight of clinical trials in the EU, and EMA's new responsibilities in this area.
Data analytics and AI
- EMA and FDA set common principles for AI in medicine development
- Ongoing clinical trials raw data pilot
- Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation
- Vaccine Monitoring Platform
- Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use
- Data Analysis and Real World Interrogation Network (DARWIN EU)
- Reflection paper on the use of artificial intelligence in the lifecycle of medicines
Scientific advice and protocol assistance
PRIME: a scheme for unmet patient needs
Electronic product information (ePI)
European medicines agencies network strategy
How EMA supports SMEs
Pharmacovigilance
To find out more, see:
Quality innovation group
Paediatric medicines
Information management
EMA's work in the international arena
EMA’s cooperation with regional and national health technology assessment bodies.
EMA and the European Commission's Directorate-General for International Partnerships signed an agreement in December 2023. It underpins EMA's support for setting up the African Medicines Agency through to November 2027.
Fees payable to the European Medicines Agency
Job opportunities
Supporting innovation
Qualification of novel methodologies for medicine development
The European Medicines Agency offers scientific advice to support the qualification of innovative development methods for a specific intended use in the context of research and development into pharmaceuticals.
More information: