Who we are
Table of contents
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
EMA is governed by an independent Management Board. Its day-to-day operations are carried out by the EMA staff, overseen by EMA's Executive Director.
EMA is a networking organisation whose activities involve thousands of experts from across Europe. These experts carry out the work of EMA's scientific committees.
On 2 March 2020, EMA implemented changes to its organisational structure to ensure that it operates as efficiently as possible to deliver high quality outputs for public and animal health.
The main changes comprise:
- integrating operations in the area of human medicines into one human medicines division;
- establishing four mission-critical task forces to support the human and veterinary medicines divisions, bringing together expertise to drive transformational change in high-priority areas.
The re-organisation exercise takes into account the rapidly evolving landscape for pharmaceutical research and development that requires regulators to keep up with advances in science and technology and prepare for future challenges at an ever-accelerating pace.
The change is also driven by the need to recalibrate to a lower head count following the EMA's relocation to Amsterdam in 2019 whilst dealing with an increased workload due the implementation of various new legislation relating to clinical trials, veterinary medicines, medical devices and data protection.
The Management Board consists of 36 members, appointed to act in the public interest, who do not represent any government, organisation or sector.
The Board sets the Agency's budget, approves the annual work programme and is responsible for ensuring that the Agency works effectively and co-operates successfully with partner organisations across the EU and beyond.
The Agency's Executive Director is the legal representative of the Agency. She is responsible for all operational matters, staffing issues and drawing up the annual work programme.
The Agency's staff support the Executive Director in carrying out their responsibilities, including administrative and procedural aspects of EU law related to the evaluation and safety-monitoring of medicines in the EU.
EMA has seven scientific committees that evaluate medicines along their lifecycle from early stages of development, through marketing authorisation to safety monitoring once they are on the market.
In addition, the Agency has a number of working parties and related groups, which the committees can consult on scientific issues relating to their particular field of expertise.
These bodies are composed of European experts made available by national competent authorities of the EU Member States, which work closely with EMA in the European medicines regulatory network.