The agency was located in London prior to the United Kingdom's vote for withdrawal from the European Union, relocating to Amsterdam in March 2019.

[8] More specifically, it coordinates the evaluation and monitoring of centrally authorised products and national referrals, develops technical guidance and provides scientific advice to sponsors.

The Management Board provides administrative oversight to the Agency: including approval of budgets and plans, and selection of executive director.

The EMA additionally engages with international agencies and non-governmental organizations on areas of mutual interest, such as its participation on the Coalition for Epidemic Preparedness Innovations' Joint Coordination Group.

A special type of approval is the paediatric-use marketing authorisation (PUMA), which can be granted for medical products intended exclusively for paediatric use.

[16] The CHMP is obliged by the regulation to reach decisions within 210 days, though the clock is stopped if it is necessary to ask the applicant for clarification or further supporting data.

The centralised procedure is also open to products that bring a significant therapeutic, scientific or technical innovation, or is in any other respect in the interest of patient or animal health.

The agency was located in London prior to the United Kingdom's vote for withdrawal from the European Union, relocating to Amsterdam in March 2019.

[28] The EU's Health Commissioner Vytenis Andriukaitis said that the preferred choice would be a location where an "easy set up and guarantee of smooth operations" would be available.

Member states who had expressed their bid for the new EMA location were Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden (or in other words all remaining member countries except for the Baltic States and Luxembourg).

[40][41] The decision on the relocation was made on 20 November 2017, during the EU General Affairs Council meeting,[41] after three voting rounds and finally drawing of lots.

[1] The EMA played a significant role in the response to the COVID-19 pandemic in the European Union, seeking to expedite the development and approval of COVID-19 vaccines and treatments.

[44] While in the process of evaluating the Pfizer–BioNTech COVID-19 vaccine in December 2020, the EMA suffered a cyberattack, resulting in the leak of classified regulatory documents to journalists, academics and the public via the dark web.

[45][46][47] The documents revealed internal concerns about low production quality in the mRNA vaccine candidate, and regulators' efforts to have Pfizer and BioNTech rectify these deficiencies.