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The European Medicines Agency's scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.
HumanBiologicalsRegulatory and procedural guidanceResearch and developmentScientific guidelines
HumanBiologicalsRegulatory and procedural guidanceResearch and developmentScientific guidelines
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.
HumanCOVID-19Clinical trialsCompassionate useRegulatory and procedural guidanceMedicine shortagesResearch and developmentScientific advice
NewsHumanCOVID-19Research and development
NewsHumanCOVID-19Research and development
NewsHumanCOVID-19Research and developmentVaccines
Press releaseHumanCOVID-19MedicinesResearch and development
Press releaseHumanCOVID-19Clinical trialsQuality of medicinesResearch and developmentVaccines
Press releaseHumanCOVID-19Clinical trialsMedicinesResearch and development
Press releaseHumanCOVID-19Research and development