Big data

Massive amounts of data are generated on a daily basis that could potentially be harnessed to support medicines regulation. The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) set up a joint task force to describe the big data landscape from a regulatory perspective and identify practical steps for the European medicines...

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HumanVeterinaryCorporateData on medicinesInnovationResearch and development
Guidance for medicine developers and other stakeholders on COVID-19

During the 2020-23 COVID-19 public health emergency, the European Medicines Agency (EMA) provided guidance for medicine developers and pharmaceutical companies to help speed up development and approval for COVID-19 medicines and address regulatory challenges arising from the pandemic.

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HumanCOVID-19Clinical trialsCompassionate useRegulatory and procedural guidanceMedicine shortagesResearch and developmentScientific advice
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HumanVeterinaryData on medicinesRegulatory and procedural guidanceResearch and development