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
Compassionate use
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HumanCompassionate useEarly accessRegulatory and procedural guidanceResearch and development
Multidisciplinary: biosimilar

The European Medicines Agency's scientific guidelines on biosimilar medicinal products help medicine developers prepare marketing authorisation applications for human medicines.

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HumanBiosimilarsRegulatory and procedural guidanceResearch and developmentScientific guidelines