What we do

The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU).

What we do

From lab to patient: journey of a medicine (new)

Interactive timeline - Lab to patients thumbnailFollow the journey of a medicine for human use assessed by EMA in this interactive timeline. It explains all stages from initial research to patient access, including how EMA supports medicine development, assesses the benefits and risks and monitors the safety of medicines. 

The full text is available as a  PDF iconbooklet

EMA plans to publish the booklet in all EU languages in 2020.

Facilitate development and access to medicines

EMA is committed to enabling timely patient access to new medicines, and plays a vital role in supporting medicine development for the benefit of patients.

The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved. For more information see:

EMA also plays a role in supporting research and innovation in the pharmaceutical sector, and promotes innovation and development of new medicines by European micro-, small- and medium-sized-enterprises. 

Evaluate applications for marketing authorisation

EMA's scientific committees provide independent recommendations on medicines for human and veterinary use, based on a comprehensive scientific evaluation of data.

The Agency's evaluations of marketing-authorisation applications submitted through the centralised procedure provide the basis for the authorisation of medicines in Europe.

They also underpin important decisions about medicines marketed in Europe, referred to EMA through referral procedures. EMA coordinates inspections in connection with the assessment of marketing-authorisation applications or matters referred to its committees.

Monitor the safety of medicines across their lifecycle

EMA continuously monitors and supervises the safety of medicines that have been authorised in the EU, to ensure that their benefits outweigh their risks. The Agency works by:

  • developing guidelines and setting standards;
  • coordinating the monitoring of pharmaceutical companies' compliance with their pharmacovigilance obligations;
  • contributing to international pharmacovigilance activities with authorities outside the EU;
  • informing the public on the safety of medicines and cooperating with external parties, in particular representatives of patients and healthcare professionals.

For more information see Pharmacovigilance.

Provide information to healthcare professionals and patients

The Agency publishes clear and impartial information about medicines and their approved uses. This includes public versions of scientific assessment reports and summaries written in lay language. For more information see:

 

What we don't do

Not all aspects of medicine regulation in the EU fall under the remit of the Agency. EMA does not:

EMA often receives questions about the scope of its work. See a list of Frequently asked questions.

More information

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