The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU). It is responsible for the scientific evaluation, supervision and monitoring of drug safety.
Its activities are as follows:
- Facilitating the development of and access to medicines, through various regulatory mechanisms, support for research, publication of guidelines on requirements for quality, safety and efficacy testing of medicines, facilitation of a working group on innovation, etc. The EMA is also responsible for monitoring and mitigating potential or actual shortages of critical medicines caused by major events and in crisis situations.
- Evaluating marketing authorization applications: EMA’s Scientific Committees issue independent recommendations on human and veterinary medicines, based on a comprehensive scientific evaluation of the data. The Agency’s evaluation of marketing authorization applications submitted under the centralized procedure system forms the basis for the authorization of medicinal products in Europe.
- Monitor the safety of medicines throughout their life cycle, notably through pharmacovigilance.
- Provide information to healthcare professionals and patients.
The EMA’s role and activities in the field of animal use are presented on this page. The Innovation Working Group discusses the regulatory acceptability of New Approach Methodologies (NAMs) to replace animal use in drug testing. The Agency has also drafted several recommendations on the application of the 3Rs.
The 3Rs working party has produced a 3-year plan (2025-2027) for the pre-clinical field.
