Requirement for sponsor to publish summary clinical trial results

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT) 

The letter and a supporting press release are available from the EMA website.   

We would encourage clinical trial sponsors in Ireland to visit the EMA website to access this information. There are additional links to materials and tools which are available to stakeholders in order to provide them with information and guidance on reporting trial results to EudraCT.