Clinical Trial Competitive multinational assessment timelines in the European Union ensuring Regulatory Excellence

ended

Therapeutics continue to play a critical role in the response to the COVID-19 pandemic. They help to save lives, speed up recovery time and help to avoid or reduce periods of hospitalisation. However, joint efforts are still needed to ensure access to safe and effective therapeutics. The EU Strategy on COVID-19 therapeutics highlighted that robust clinical trials are an essential source of evidence for the authorisation of innovative COVID-19 medicines and there is a need for speeding up and coordinating their authorisation. This joint action supports Member States to ensure expedited and coordinated assessments in a procedure conform to the Clinical Trial Regulation (EU) 536/2014 but with timelines assuring expedited assessment and decision. This will allow for a fast authorisation of harmonised clinical trial protocols for COVID-19 therapeutics in the Union and will make the Union more attractive to run large, multi-country trials The joint action is expected to result in an increase in the number of coordinated assessments of COVID-19 therapeutics’ clinical trials and on a reduction of the time needed to authorise such trials.