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Questions about European Medicines Agency

Short answers, pulled from the story.

When was the European Medicines Agency founded?

The European Medicines Agency was founded in 1995, after more than seven years of negotiations among EU governments. It was set up with funding from the European Union, the pharmaceutical industry, and indirect subsidies from member states.

Why did the European Medicines Agency move from London to Amsterdam?

The EMA relocated because the United Kingdom voted to leave the European Union in 2016, and EU law required the agency to be located within EU territory. The relocation decision was made on the 20th of November 2017 after three voting rounds and a drawing of lots, with Amsterdam selected as the new host city. Staff left London in March 2019 and moved into the permanent building in Amsterdam's Zuidas district by January 2020.

How long does the European Medicines Agency take to approve a medicine?

The Committee for Medicinal Products for Human Use is required by regulation to reach decisions within 210 days, though the clock is paused if clarification or additional data is needed from the applicant. This compares with an average of around 500 days at the U.S. Food and Drug Administration as of 2008.

What happened to the European Medicines Agency during the COVID-19 pandemic?

In December 2020, while evaluating the Pfizer-BioNTech COVID-19 vaccine, the EMA suffered a cyberattack that resulted in the leak of classified regulatory documents via the dark web. The documents revealed internal concerns about low production quality in the mRNA vaccine and regulators' efforts to have Pfizer and BioNTech address those deficiencies. The EMA authorised the vaccine on the 21st of December 2020.

What is orphan drug status and how does the European Medicines Agency grant it?

Orphan drug status is a designation for medicines targeting conditions that affect not more than five in 10,000 persons in the European Union. The Committee on Orphan Medicinal Products has administered the granting of this status since 2000; it evaluates applications and makes a recommendation, which is then formally granted by the European Commission.

How many experts does the European Medicines Agency draw on to evaluate medicines?

The EMA works through a network of approximately 4,500 experts throughout the EU and draws on resources from over 40 National Competent Authorities of EU member states. The agency's internal Secretariat runs to around 600 staff.