The European Medicines Agency (EMA), a decentralised Agency of the EU, took up its function in 1995.
EMA’s mission is to evaluate and supervise human and veterinary medicinal products, on grounds of safety, efficacy and quality, in order to protect human and animal health in the EU. EMA does not conduct itself research (no laboratory work, animal tests, or clinical trials), nor does it produce medicines.
EMA receives application files and information from various sources e.g. industry, Member States, health professionals, patients. Its mission is to coordinate the scientific expertise and resources of Member States, who assess this scientific information in the setting of “committees”, and provide scientific opinions. EMA relies on its internal expertise provided by its staff as well as on the external scientific expertise provided by the Member States. EMA’s key activities consist in:
- Providing a single route for the evaluation of innovative medicines in the EU, hereby avoiding the duplication of the evaluation in Member States (centralised procedure).
- Monitoring the safety of all medicines authorised in the EU throughout their life cycle.
- Stimulating research and innovation by giving scientific advice and guidance to developers of medicines.
- Coordinating inspections to verify the compliance with good manufacturing, clinical and laboratory practices.
- Hosting IT services to implement the EU pharmaceutical policy and legislation.
Key figures (2015):
The EMA staff
The EMA has
of offices space
EMA builds on the
scientific knowledge of
experts from across the EU
36,000 visitors (staff of national competent authorities, scientists, patients, health professionals, industry), including 4,000 non-EU visitors requiring intercontinental flights (US, Japan, Korea etc.), visited the Agency for meetings lasting up to 4 days.
30,000 hotel nights were booked, with a daily peak hotel capacity of 350 rooms needed.
648 children of EMA staff aged 0 to 18 were schooled in September 2016 (117 in nursery/day care, 96 in pre-school, 231 in primary school, 149 in second level and 55 third level/university).