The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU). The Council Regulation (EEC) No 2309/93, adopted on 22 July 1993, established creation of the agency. The Agency was inaugurated on 26 January 1995.
Originally based in London, EMA moved to Amsterdam in 2019 following the UK’s exit from the EU.

EMA protects public and animal health in the Member States and in the countries of the European Economic Area (EEA) by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA is responsible for the centralised procedure for the authorisation of medicines resulting in a single evaluation and a single authorisation for the whole of the EU. The centralised procedure is compulsory for certain medicines, including human medicines intended for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases; medicines derived from biotechnology processes, such as genetic engineering; advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines; orphan medicines (medicines for rare diseases); and veterinary medicines for use as growth or yield enhancers. EMA’s recommendations are based on rigorous scientific standards and available evidence.

To perform its tasks, EMA brings together scientific experts from across Europe. The European medicines regulatory network is the system for regulating medicines in Europe and is based on a closely coordinated regulatory network of national competent authorities in the EEA Member States working together with EMA and the European Commission. EMA coordinates the work of around 4,500 experts who are involved in the scientific evaluation of medicines and serve as members of the Agency’s scientific Committees, working parties, shortages steering groups, Emergency Task Force and other groups.

Over the years, EMA’s scope has increased under EU legislation. And in response to the COVID-19 pandemic, its role has expanded even further with new mandates to tackle emerging challenges such as coordinating national responses to medicines shortages, supporting innovation, particularly in crisis situations, but also in preparation for other emerging health threats.

Decentralised Agency of the European Union.

EMA’s mission is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the EU. Among many other things, EMA performs the following tasks:

- Facilitate innovation and development and enable timely patient access to new medicines through a wide range of regulatory mechanisms.
- Prepare for and manage crisis situations affecting the single market for medicines and medical devices.
- Evaluate marketing authorisation applications for medicines for human and veterinary use through the centralised procedure.
- Monitor and supervise continuously the safety of medicines that have been authorised in the EU, to ensure that their benefits outweigh their risks.
- Provide information on medicines to healthcare professionals and patients.

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)
https://eur-lex.europa.eu/eli/reg/2004/726/oj/eng
Complete Legal framework
https://www.ema.europa.eu/en/about-us/what-we-do/legal-framework