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HumanVeterinaryCompliance and inspectionsRegulatory and procedural guidanceResearch and development
HumanCompliance and inspectionsRegulatory and procedural guidanceResearch and development
HumanCompliance and inspectionsRegulatory and procedural guidanceResearch and development
HumanCompliance and inspectionsRegulatory and procedural guidanceResearch and development
HumanVeterinaryCompliance and inspectionsRegulatory and procedural guidanceResearch and development
EventHumanClinical trialsQuality of medicinesResearch and development
HumanCompliance and inspectionsRegulatory and procedural guidanceResearch and development
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
HumanCompliance and inspectionsRegulatory and procedural guidanceResearch and development
European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.
HumanClinical trialsRegulatory and procedural guidanceResearch and development