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The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission. CTIS went live with a searchable public website on 31 January 2022.

Human Clinical trials
Medicine Human Authorised
Medicine Human Authorised
Medicine Human Authorised
Medicine Human Authorised
Medicine Human Authorised

The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and summary of product characteristics, together with a short...

Human Regulatory and procedural guidance Pharmacovigilance