What we do

The European Medicines Agency (EMA) fosters scientific excellence in the evaluation and supervision of medicines. This benefits public and animal health in the European Union (EU).

Updated on 6 November 2025:
'Monitor the safety of medicines across their lifecycle' section

For more information on EMA's work, see:

• About us

In this section

Authorisation of medicines

EMA's role in the centralised authorisation procedure for medicines marketed in the EU. Summary of the national authorisation procedure

Crisis preparedness and management

EMA's role in preparing for and managing crisis situations affecting the EU's single market for medicines and medical devices

Legal framework

An explainer of the principles governing the placing of medicines on the EU's single market

Regulatory science research

How EMA supports innovation and ensures availability of medicines for human and veterinary use

More on what EMA does

EMA also engages in the following activities:

• Supports early patient access to new medicines
• Scientific advice and protocol assistance
• Paediatric procedures
• Scientific support for advanced-therapy medicines
• Orphan designation of medicines for rare diseases
• Scientific guidelines on requirements for the quality, safety and efficacy testing of medicines
• Offers early dialogue for developers of innovative medicines

For more information, see:

• Support for early access
• Scientific advice and protocol assistance
• Paediatric medicines: Overview
• Advanced therapy medicinal products: Overview
• Orphan designation: Overview
• Scientific guidelines
• Supporting innovation

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.

We use a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved.

EMA 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. 

For more information, see:

• Regulatory science research
• Support to SMEs

The journey of a medicine assessed by EMA

Check our interactive timeline for an overview of all stages in the product lifecycle from initial research to patient access

Check our timeline

The journey of a medicine assessed by EMA - text versions in EU languages

From laboratory to patient: the journey of a centrally authorised medicine

Who does initial research on medicines?

The initial research on medicines is usually done by pharmaceutical and biotechnology companies – some big companies develop many medicines, while others are small companies who may only be researching one or two.

Doctors and academics also perform research, and may get together to research either new medicines or new uses of old medicines. Such researchers, either in public institutions or private companies, investigate vast numbers of substances for their potential as medicines each year.

However, only a small proportion of the compounds investigated will ever be promising enough to progress to further development.

Did you know

Developers of innovative treatments can discuss the scientific, legal and regulatory aspects of their medicine with EMA early in the development through the Innovation Task Force.

In 2018, 9 of 22 such requests for early discussions came from university-based or academic groups.

For more information, see:

• Supporting innovation

How are potential new medicines tested?

Potential new medicines are tested first in the laboratory and then in human volunteers, in studies called clinical trials. These tests help us to understand how the medicines work and to evaluate their benefits and side effects.

Medicine developers who wish to conduct clinical trials in the EU need to submit applications to the national competent authorities of the countries where they want to conduct the trials.

EMA does not have a role in the authorisation of clinical trials in the EU. This is the responsibility of the national competent authorities.

However, EMA, in cooperation with the EU Member States, plays a key role in ensuring that medicine developers follow EU and international standards.

Whether they conduct these studies within or outside the EU, developers conducting studies to support the marketing authorisation of a medicine in the EU have to comply with strict rules. These rules, called Good clinical practice, apply to the way they design the studies, how they record their results and how they report these results. These rules are in place to ensure that studies are scientifically sound and conducted in an ethical manner.

For more information, see:

• Clinical trials in human medicines
• Good clinical practice

Can EMA influence which medicines should be developed?

EMA cannot sponsor medicines or fund research studies for a specific medicine, nor can it force companies to research particular medicines or treatments for a particular condition.

Being a medicines regulator, EMA has to be neutral and cannot have a financial or other interest in any medicine being developed.

However, EMA can, and does, publicise areas where there is a need for new medicines – for example, new antibiotics – to encourage interested parties to research them. 

In addition, the EU legislation provides measures to encourage companies to develop medicines for rare diseases. These include for example fee reductions when obtaining scientific advice from EMA.

Also provided by the EU legislation is a system of obligations, rewards and incentives to encourage manufacturers to research and develop medicines for children.

For more information, see:

• Orphan designation: Overview
• Paediatric medicines: Overview

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.

For more information, see:

• Committees, working parties and other groups
• Authorisation of medicines
• Referral procedures: human medicines
• Inspections procedures

Monitor the safety of medicines across their lifecycle

EMA continuously monitors and supervises the safety of medicines that have been authorised in the EU. This ensures that their benefits outweigh their risks. 

Before a medicine is approved, we carefully assess its benefits and risks. A medicine can only be authorised if data show that its benefits are greater than its risks.

After approval, we continuously monitor medicines to detect and manage any new safety concerns.

Throughout, we work with national competent authorities (NCAs) in each EU country to ensure medicines are used as safely as possible. 

For more information, see:

• Safety of medicines

Provide information to healthcare professionals and patients

EMA 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:

• Transparency
• Search human medicines
• Search veterinary medicines

What we don't do

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

• evaluate the initial marketing authorisation application of all medicines in the EU - the majority of medicines available in the EU are authorised at national level;
• evaluate applications for the authorisation of clinical trials - the authorisation of clinical trials occurs at EU Member State level, although EMA plays a key role in ensuring that the standards of good clinical practice are applied in cooperation with the Member States and manages a database of clinical trials carried out in the EU.
• evaluate medical devices -  national competent authorities in Europe regulate medical devices, while EMA is involved in the assessment of certain categories of medical devices.
• evaluate food supplements and cosmetics - these substances are evaluated at national level;
• carry out research or develop medicines - pharmaceutical companies or other medicines developers carry out the research and development of medicines, who then submit the findings and test results for their products to EMA for evaluation.
• take decisions or have information on the price or availability of medicines - decisions about price and reimbursement take place at the level of each Member State in the context of the national health system of that country.
• control the advertising of medicines - the control of the advertising of non-prescription medicines in the EU is primarily conducted on a self-regulatory basis by industry bodies, supported by the statutory role of the national regulatory authorities in the Member States;
• control or have information on pharmaceutical patents - patents having effect in most European countries may be obtained either nationally, via national patent offices, or via a centralised process at the European Patent Office;
• develop treatment guidelines - national governments or the health authorities of individual EU Member States develop guidelines for decisions regarding diagnosis, management, and treatment in specific areas of healthcare (sometimes known as clinical guidelines);
• provide medical advice - healthcare professionals can provide individual patients advice on medical conditions, treatments or side effects with a medicine;
• develop laws concerning medicines - the European Commission develops EU legislation concerning medicines and the European Parliament together with the Council of the European Union adopt it; the European Commission also develops EU policies in the field of human or veterinary medicines and public health.
• issue marketing authorisations - the legal decision to grant, suspend or revoke a marketing authorisation for any medicine falls under the remit of the European Commission for centrally authorised products, and the national competent authorities of the EU Member States for nationally authorised products.

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

For more information, see:

• Authorisation of medicines
• Clinical trials in human medicines
• Medical devices
• Health-technology-assessment bodies
• National competent authorities (human)
• EU Member States