Select Page
Skip to main content
Documentation
Categories
< All Topics
Print

Roles and Responsibilities of the European Medicines Agency (EMA)

Updated

The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in the European Union (EU) and European Economic Area (EEA). The Agency was historically referred to as the European Medicines Evaluation Agency (EMEA), and the abbreviation EMEA may therefore appear in older regulatory documents and literature.

Role of EMA

EMA works as part of the European medicines regulatory network in cooperation with the national competent authorities of EU and EEA countries and the European Commission. Its scientific committees provide independent scientific recommendations based on the evaluation of data concerning the quality, safety and efficacy of medicines.

For medicines submitted through the centralised marketing authorisation procedure, EMA coordinates the scientific assessment. The European Commission subsequently makes the legally binding decision on whether to grant, refuse, suspend or revoke the marketing authorisation.

Major Responsibilities of EMA

The principal responsibilities of EMA include:

  • Coordinating the scientific evaluation of applications for centrally authorised medicines.
  • Monitoring the safety of medicines throughout their lifecycle.
  • Coordinating pharmacovigilance activities and assessment of safety signals and risks.
  • Providing scientific advice and regulatory support to medicine developers.
  • Supporting the development of medicines for children, rare diseases and advanced therapies.
  • Developing scientific guidelines and regulatory guidance.
  • Coordinating certain inspections associated with marketing authorisation procedures.
  • Providing reliable information about medicines to healthcare professionals, patients and the public.
  • Supporting cooperation and harmonisation among regulatory authorities in Europe and internationally.

EMA and Clinical Trials

EMA plays an important role in the European clinical-trial regulatory system, including the management of the Clinical Trials Information System (CTIS). However, EMA itself does not authorise individual clinical trials. Clinical-trial applications are assessed and authorised by the competent authorities of EU/EEA Member States under the applicable European regulatory framework.

Importance of EMA

EMA contributes to the protection and promotion of public and animal health by ensuring that medicines evaluated through its procedures meet appropriate standards of quality, safety and efficacy. Its activities support consistent scientific assessment, pharmacovigilance and regulatory decision-making across the European medicines regulatory network.

You may be interested in the programs below: