EMA has a 30-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines.
EMA's success is based on cooperation within the European medicines regulatory network – a unique partnership between the European Commission, the medicines regulatory authorities in the European Economic Area countries, and EMA. Working together has encouraged the exchange of knowledge, ideas and best practices, in order to ensure the highest standards in medicines regulation.
EMA's work relies on seven committees. Five of these include patients and healthcare professionals. They play a vital role in the assessment of the risks and benefits of medicines along their lifecycle.
In addition, more than 30 EMA working parties provide scientific expertise for the regulation of medicines. They draw on a pool of several thousand European scientific experts from 27 Member States, and Iceland, Norway and Liechtenstein.
To find out more about EMA's role, see:
2025 marks EMA's 30th anniversary.
Its work is enabling 450 million EU citizens and countless animals in Europe and beyond to benefit from innovative medicines authorised centrally.
To mark the anniversary, EMA organises a scientific conference that will take place on 25 June 2025: EMA’s 30th anniversary scientific conference - Medicines, regulation and the future
EMA celebrates alongside more than 1,000 employees and 4,000 experts in the EU medicines regulatory network.
Watch the video below for an overview of key milestones and achievements in the authorisation and safety monitoring of medicines for human and animal use in the EU.
EMA was set up in 1995 to harmonise the work of existing national medicine regulatory bodies.
The Agency's remit has expanded over time, in line with new EU legislation.
On top of its remit to evaluate human and veterinary medicines, EMA is also responsible for products developed in the specialised areas of medicines for rare diseases (since 2000), herbal medicines (since 2004), medicinesfor children (since 2006) and advanced-therapy medicines (since 2007).
Acquiring these responsibilities resulted in new scientific committees which provide the expertise in these areas.
With the establishment of the Committee for Orphan Medicinal Products in 2000, EMA opened its doors to patients and healthcare professionals.
Currently, their representatives take part in most of EMA's scientific committees as full members, where they add their unique perspective and experiences to discussions.
In 2014, patients discussed the benefit-risk evaluation of a medicine within the Committee for Medicinal Products for Human Use (CHMP) for the first time.
With the creation of the Pharmacovigilance and Risk Assessment Committee (PRAC) in 2012, EMA started to play an even more important role in monitoring the safety of medicines across Europe.
As of January 2015, EMA has been implementing its landmark policy on publishing the clinical data that underpin European decision-making on medicines. This will provide an unprecedented level of transparency for patients, healthcare professionals, academia and industry.
As of 2020, EMA made substantial progress by:
As of 2022, EMA prepared for and implemented new regulations:
In 2025, EMA is preparing for the new pharmaceutical legislation.
2015 marked the 50th anniversary of the introduction of the first EU legislation on human medicines.
On 26 January 1965, the Council Directive 65/65 on the approximation of the law relating to medicinal products was adopted.
To mark the anniversary, the European Commission held a conference entitled '50 Years of EU Pharma legislation: Achievements and future perspectives'.
This reviewed the role of EU pharmaceutical legislation in protecting public health, and in promoting advances in science, innovation and health.
For more information, see:
