The European Medicines Agency (EMA) has close ties with all of the European Union (EU) institutions involved in developing EU laws concerning medicines and the regulation of medicines.
The European Commission takes binding decisions on the authorisation of medicines valid throughout the EU. It bases its decisions on scientific assessments by EMA's scientific committees, ensuring that medicines comply with high quality, safety and efficacy standards.
The European Commission also:
- proposes or amends legislation for the pharmaceutical sector;
- adopts implementing measures and ensures the correct application of EU law;
- collaborates with relevant international partners and promotes the EU system globally.
EMA has daily contact with the Commission's Directorate General for Health and Food Safety (DG SANTE), which deals with issues concerning the regulation of medicines. DG SANTE is represented on EMA's Management Board and its officials regularly attend the Agency's scientific and stakeholder meetings as observers.
EMA participates in the European Commission's pharmaceutical committees and relevant expert groups for human and veterinary medicines and its Health Security Committee.
EMA also provides input to the Commission on major European public health issues, including support for drafting relevant legislation.
The European Parliament, together with the Council of the European Union, adopt EU legislation concerning the regulation of medicines proposed by the European Commission.
Within the European Parliament, the Committee for Environment, Public Health and Food Safety (ENVI) deals with issues concerning EMA. The ENVI follows the work of EMA closely.
By invitation, EMA's Executive Director and senior staff attend ENVI meetings to provide updates on EMA's work to Members of the European Parliament and exchange views on issues of interest.
Council of the European Union
The Council of the European Union, together with the European Parliament, adopt EU legislation concerning the regulation of medicines proposed by the European Commision.
The Health Ministers of the Member States meet in the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO).
EPSCO may seek EMA's opinion on public health issues, in particular those concerning communicable diseases. For more information, see Public health threats and pandemics.
EMA may also attend informal Council working party meetings relevant to its work.